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Trial record 21 of 50 for:    BI 201335 OR faldaprevir

Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID and Multiple Doses of BI 207127 Combined With Faldaprevir in Healthy Male and Female Subjects

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ClinicalTrials.gov Identifier: NCT01737996
Recruitment Status : Completed
First Posted : November 30, 2012
Results First Posted : April 8, 2016
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Intervention Drug: BI 207127 + faldaprevir
Enrollment 32
Recruitment Details  
Pre-assignment Details The 600mg dose cohort was to be started at least 6 days after the 400mg dose cohort was completed and the combined treatment cohort (600mg Deleobuvir + 120mg Faldaprevir) was started after the evaluation of key safety and tolerability data of the individual treatments.
Arm/Group Title 400 mg Deleobuvir 600 mg Deleobuvir 600 mg Deleobuvir + 120 mg Faldaprevir
Hide Arm/Group Description 400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose (MRD) part. 600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose (MRD) part.

600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.

Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part.

Period Title: Overall Study
Started 8 8 16
Completed 8 7 14 [1]
Not Completed 0 1 2
Reason Not Completed
Adverse Event             0             1             1
Withdrawal by Subject             0             0             1
[1]
One patient withdrew consent after the first dose due to private reasons.
Arm/Group Title 400 mg Deleobuvir 600 mg Deleobuvir 600 mg Deleobuvir + 120 mg Faldaprevir Total
Hide Arm/Group Description 400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part. 600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.

600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.

Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part.

Total of all reporting groups
Overall Number of Baseline Participants 8 8 16 32
Hide Baseline Analysis Population Description
The study comprised 2 trial parts: a multiple rising dose part (Part 1) followed by a combined treatment part (Part 2). The multiple rising dose part was performed in an open-label, non-randomised, non-placebocontrolled manner with 2 dose groups. The combined treatment part was conducted open-label in 1 treatment group.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 16 participants 32 participants
39.5  (10.4) 37.3  (5.1) 38.3  (10.6) 38.3  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants 32 participants
Female
3
  37.5%
4
  50.0%
6
  37.5%
13
  40.6%
Male
5
  62.5%
4
  50.0%
10
  62.5%
19
  59.4%
1.Primary Outcome
Title Number of Healthy Subjects With AEs (Multiple Rising Dose Part)
Hide Description Number of healthy subjects with any adverse event (AE) during the on-treatment period.
Time Frame From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Set. The treated set included all subjects who were documented to have taken at least 1 dose of study medication.
Arm/Group Title 400 mg Deleobuvir 600 mg Deleobuvir
Hide Arm/Group Description:
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
Overall Number of Participants Analyzed 8 8
Measure Type: Number
Unit of Measure: participants
6 5
2.Primary Outcome
Title AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Combined Treatment Part)
Hide Description Area under the concentration-time curve (AUC) of Deleobuvir over the uniform dosing interval 0 to 12 h (hours) on Day 1 and at steady state on Day 16.
Time Frame After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 hours (h) after drug administration in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS. The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least 1 observation for at least 1 pharmacokinetic endpoint without important protocol violations relevant for the statistical evaluation of pharmacokinetic endpoints. Including patients with available data.
Arm/Group Title 600 mg Deleobuvir + 120 mg Faldaprevir
Hide Arm/Group Description:

600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.

Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part.

Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
AUC(0-12h) on Day 1
37500
(49.4%)
AUC(0-12h,ss) on Day 16
51400
(57.2%)
3.Primary Outcome
Title Cmax and Cmax,ss of Deleobuvir (Combined Treatment Part)
Hide Description Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 16.
Time Frame After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS including patients with available data.
Arm/Group Title 600 mg Deleobuvir + 120 mg Faldaprevir
Hide Arm/Group Description:

600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.

Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part.

Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Cmax on Day 1
6930
(47.9%)
Cmax,ss on Day 16 (N=14)
9710
(43.3%)
4.Primary Outcome
Title C(12h) and C(12h,ss) of Deleobuvir (Combined Treatment Part)
Hide Description Concentration of Deleobuvir at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.
Time Frame After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS including patients with available data.
Arm/Group Title 600 mg Deleobuvir + 120 mg Faldaprevir
Hide Arm/Group Description:

600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.

Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part.

Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
C(12h) on Day 1
1090
(69.3%)
C(12h,ss) on Day 16
1000
(85.9%)
5.Primary Outcome
Title AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Combined Treatment Part)
Hide Description

Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.

CD 6168 is a major metabolite of Deleobuvir.

Time Frame After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS including patients with available data.
Arm/Group Title 600 mg Deleobuvir + 120 mg Faldaprevir
Hide Arm/Group Description:

600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.

Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part.

Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
AUC(0-12h) on Day 1
6080
(55.0%)
AUC(0-12h,ss) on Day 16
38100
(76.0%)
6.Primary Outcome
Title Cmax and Cmax,ss of CD 6168 (Combined Treatment Part)
Hide Description

Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 16.

CD 6168 is a major metabolite of Deleobuvir.

Time Frame After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS including patients with available data.
Arm/Group Title 600 mg Deleobuvir + 120 mg Faldaprevir
Hide Arm/Group Description:

600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.

Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part.

Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Cmax on Day 1
902
(49.2%)
Cmax,ss on Day 16
4860
(60.5%)
7.Primary Outcome
Title C(12h) and C(12h,ss) of CD 6168 (Combined Treatment Part)
Hide Description

Concentration of CD 6168 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.

CD 6168 is a major metabolite of Deleobuvir.

Time Frame After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS including patients with available data.
Arm/Group Title 600 mg Deleobuvir + 120 mg Faldaprevir
Hide Arm/Group Description:

600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.

Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part.

Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
C(12h) on Day 1
488
(67.5%)
C(12h,ss) on Day 16
1650
(102.0%)
8.Primary Outcome
Title AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Combined Treatment Part)
Hide Description

Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.

BI 208333 is a major metabolite of Deleobuvir.

Time Frame After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS including patients with available data.
Arm/Group Title 600 mg Deleobuvir + 120 mg Faldaprevir
Hide Arm/Group Description:

600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.

Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part.

Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
AUC(0-12h) on Day 1
9130
(46.9%)
AUC(0-12h,ss) on Day 16
13600
(71.1%)
9.Primary Outcome
Title Cmax and Cmax,ss of BI 208333 (Combined Treatment Part)
Hide Description

Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 16.

BI 208333 is a major metabolite of Deleobuvir.

Time Frame After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS including patients with available data.
Arm/Group Title 600 mg Deleobuvir + 120 mg Faldaprevir
Hide Arm/Group Description:

600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.

Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part.

Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Cmax on Day 1
1450
(40.0%)
Cmax,ss on Day 16 (N=14)
2060
(57.6%)
10.Primary Outcome
Title C(12h) and C(12h,ss) of BI 208333 (Combined Treatment Part)
Hide Description

Concentration of BI 208333 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.

BI 208333 is a major metabolite of Deleobuvir.

Time Frame After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS including patients with available data.
Arm/Group Title 600 mg Deleobuvir + 120 mg Faldaprevir
Hide Arm/Group Description:

600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.

Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part.

Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
C(12h) on Day 1
520
(80.8%)
C(12h,ss) on Day 16
447
(101.0%)
11.Primary Outcome
Title AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)
Hide Description

Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.

CD 6168 acylglucuronide is a metabolite of Deleobuvir.

Time Frame After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS including patients with available data.
Arm/Group Title 600 mg Deleobuvir + 120 mg Faldaprevir
Hide Arm/Group Description:

600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.

Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part.

Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
AUC(0-12h) on Day 1
511
(69.9%)
AUC(0-12h,ss) on Day 16
3560
(120.0%)
12.Primary Outcome
Title Cmax and Cmax,ss of CD 6168 Acylglucuronide (Combined Treatment Part)
Hide Description

Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 16.

CD 6168 acylglucuronide is a metabolite of Deleobuvir.

Time Frame After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS including patients with available data.
Arm/Group Title 600 mg Deleobuvir + 120 mg Faldaprevir
Hide Arm/Group Description:

600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.

Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part.

Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Cmax on Day 1
83.9
(63.7%)
Cmax,ss on Day 16 (N=14)
457.0
(106.0%)
13.Primary Outcome
Title C(12h) and C(12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)
Hide Description

Concentration of CD 6168 acylglucuronide at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.

CD 6168 acylglucuronide is a metabolite of Deleobuvir.

Time Frame After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS including patients with available data.
Arm/Group Title 600 mg Deleobuvir + 120 mg Faldaprevir
Hide Arm/Group Description:

600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.

Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part.

Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
C(12h) on Day 1
56.4
(67.1%)
C(12h,ss) on Day 16
178.0
(122.0%)
14.Primary Outcome
Title AUC(0-24h) and AUC(0-24h,ss) of Faldaprevir (Combined Treatment Part)
Hide Description Area under the concentration-time curve of Faldaprevir over the uniform dosing interval 0 to 24 h on Day 1 and at steady state on Day 16.
Time Frame After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS including patients with available data.
Arm/Group Title 600 mg Deleobuvir + 120 mg Faldaprevir
Hide Arm/Group Description:

600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.

Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part.

Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
AUC(0-12h) on Day 1
44800
(23.6%)
AUC(0-12h,ss) on Day 16
66200
(46.1%)
15.Primary Outcome
Title Cmax and Cmax,ss of Faldaprevir (Combined Treatment Part)
Hide Description Maximum measured concentration of Faldaprevir on Day 1 and at steady state on Day 16.
Time Frame After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12, 24 h after drug administration in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS including patients with available data.
Arm/Group Title 600 mg Deleobuvir + 120 mg Faldaprevir
Hide Arm/Group Description:

600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.

Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part.

Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Cmax on Day 1
4060.0
(25.0%)
Cmax,ss on Day 16 (N=14)
5940.0
(32.3%)
16.Secondary Outcome
Title AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Multiple Rising Dose Part)
Hide Description Area under the concentration-time curve of Deleobuvir over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.
Time Frame After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS including patients with available data.
Arm/Group Title 400 mg Deleobuvir 600 mg Deleobuvir
Hide Arm/Group Description:
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
Overall Number of Participants Analyzed 8 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
AUC(0-12h) on Day 1
8210
(45.5%)
18000
(77.6%)
AUC(0-12h,ss) on Day 9
6160
(45.2%)
18500
(93.3%)
17.Secondary Outcome
Title Cmax and Cmax,ss of Deleobuvir (Multiple Rising Dose Part)
Hide Description Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 9.
Time Frame After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS including patients with available data.
Arm/Group Title 400 mg Deleobuvir 600 mg Deleobuvir
Hide Arm/Group Description:
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
Overall Number of Participants Analyzed 8 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Cmax on Day 1
2010
(41.5%)
3740
(79.4%)
Cmax,ss on Day 9
1380
(48.3%)
3650
(91.6%)
18.Secondary Outcome
Title AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Multiple Rising Dose Part)
Hide Description

Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.

CD 6168 is a major metabolite of Deleobuvir.

Time Frame After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS including patients with available data.
Arm/Group Title 400 mg Deleobuvir 600 mg Deleobuvir
Hide Arm/Group Description:
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
Overall Number of Participants Analyzed 8 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
AUC(0-12h) on Day 1
1690
(56.0%)
2920
(88.3%)
AUC(0-12h,ss) on Day 9
2810
(63.1%)
6960
(106.0%)
19.Secondary Outcome
Title Cmax and Cmax,ss of CD 6168 (Multiple Rising Dose Part)
Hide Description

Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 9.

CD 6168 is a major metabolite of Deleobuvir.

Time Frame After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS including patients with available data.
Arm/Group Title 400 mg Deleobuvir 600 mg Deleobuvir
Hide Arm/Group Description:
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
Overall Number of Participants Analyzed 8 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Cmax on Day 1
329
(60.5%)
516
(92.7%)
Cmax,ss on Day 9
451
(66.3%)
1130
(90.9%)
20.Secondary Outcome
Title AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Multiple Rising Dose Part)
Hide Description

Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.

BI 208333 is a major metabolite of Deleobuvir.

Time Frame After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS including patients with available data.
Arm/Group Title 400 mg Deleobuvir 600 mg Deleobuvir
Hide Arm/Group Description:
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
Overall Number of Participants Analyzed 8 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
AUC(0-12h) on Day 1
3940
(38.7%)
6060
(57.1%)
AUC(0-12h,ss) on Day 9
2840
(51.7%)
5270
(102.0%)
21.Secondary Outcome
Title Cmax and Cmax,ss of BI 208333 (Multiple Rising Dose Part)
Hide Description

Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 9.

BI 208333 is a major metabolite of Deleobuvir.

Time Frame After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS including patients with available data.
Arm/Group Title 400 mg Deleobuvir 600 mg Deleobuvir
Hide Arm/Group Description:
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
Overall Number of Participants Analyzed 8 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Cmax on Day 1
766
(41.5%)
1050
(54.2%)
Cmax,ss on Day 9
576
(44.4%)
983
(82.4%)
22.Secondary Outcome
Title AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Multiple Rising Dose Part)
Hide Description

Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.

CD 6168 acylglucuronide is a metabolite of Deleobuvir.

Time Frame After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS including patients with available data.
Arm/Group Title 400 mg Deleobuvir 600 mg Deleobuvir
Hide Arm/Group Description:
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
Overall Number of Participants Analyzed 7 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
AUC(0-12h) on Day 1
155
(27.2%)
342
(66.0%)
AUC(0-12h,ss) on Day 9 (N=6, 7)
256
(42.7%)
701
(94.0%)
23.Secondary Outcome
Title Cmax and Cmax,ss of CD 6168 Acylglucuronide (Multiple Rising Dose Part)
Hide Description

Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 9.

CD 6168 acylglucuronide is a metabolite of Deleobuvir.

Time Frame After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS including patients with available data.
Arm/Group Title 400 mg Deleobuvir 600 mg Deleobuvir
Hide Arm/Group Description:
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
Overall Number of Participants Analyzed 8 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Cmax on Day 1
27.3
(36.8%)
57.9
(61.0%)
Cmax,ss on Day 9
33.3
(61.3%)
116.0
(80.6%)
Time Frame From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Adverse Event Reporting Description Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
 
Arm/Group Title 400 mg Deleobuvir 600 mg Deleobuvir 600 mg Deleobuvir + 120 mg Faldaprevir
Hide Arm/Group Description 400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part. 600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.

600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.

Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part.

All-Cause Mortality
400 mg Deleobuvir 600 mg Deleobuvir 600 mg Deleobuvir + 120 mg Faldaprevir
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
400 mg Deleobuvir 600 mg Deleobuvir 600 mg Deleobuvir + 120 mg Faldaprevir
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
400 mg Deleobuvir 600 mg Deleobuvir 600 mg Deleobuvir + 120 mg Faldaprevir
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/8 (75.00%)   5/8 (62.50%)   9/16 (56.25%) 
Gastrointestinal disorders       
Abdominal pain upper  1  1/8 (12.50%)  0/8 (0.00%)  1/16 (6.25%) 
Cheilitis  1  1/8 (12.50%)  0/8 (0.00%)  0/16 (0.00%) 
Diarrhoea  1  1/8 (12.50%)  0/8 (0.00%)  5/16 (31.25%) 
Flatulence  1  0/8 (0.00%)  0/8 (0.00%)  1/16 (6.25%) 
Nausea  1  2/8 (25.00%)  3/8 (37.50%)  4/16 (25.00%) 
Vomiting  1  0/8 (0.00%)  1/8 (12.50%)  1/16 (6.25%) 
General disorders       
Fatigue  1  1/8 (12.50%)  0/8 (0.00%)  2/16 (12.50%) 
Infections and infestations       
Folliculitis  1  1/8 (12.50%)  0/8 (0.00%)  0/16 (0.00%) 
Rhinitis  1  0/8 (0.00%)  1/8 (12.50%)  0/16 (0.00%) 
Investigations       
Transaminases increased  1  0/8 (0.00%)  0/8 (0.00%)  1/16 (6.25%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  1/8 (12.50%)  0/8 (0.00%)  0/16 (0.00%) 
Nervous system disorders       
Dizziness  1  0/8 (0.00%)  1/8 (12.50%)  1/16 (6.25%) 
Headache  1  0/8 (0.00%)  1/8 (12.50%)  3/16 (18.75%) 
Reproductive system and breast disorders       
Polymenorrhoea  1  0/8 (0.00%)  0/8 (0.00%)  1/16 (6.25%) 
Respiratory, thoracic and mediastinal disorders       
Haemoptysis  1  0/8 (0.00%)  0/8 (0.00%)  1/16 (6.25%) 
Skin and subcutaneous tissue disorders       
Dry skin  1  1/8 (12.50%)  0/8 (0.00%)  1/16 (6.25%) 
Pruritus  1  1/8 (12.50%)  0/8 (0.00%)  2/16 (12.50%) 
Skin fissures  1  1/8 (12.50%)  0/8 (0.00%)  0/16 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01737996     History of Changes
Other Study ID Numbers: 1241.35
2012-003697-10 ( EudraCT Number: EudraCT )
First Submitted: November 26, 2012
First Posted: November 30, 2012
Results First Submitted: January 21, 2016
Results First Posted: April 8, 2016
Last Update Posted: April 8, 2016