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Single Rising Dose Study of BI 207127 NA in Healthy Male Asian Volunteers and Single Dose Study of BI 207127 NA in Healthy Male Caucasian Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01347086
First received: May 3, 2011
Last updated: March 16, 2016
Last verified: March 2016
Results First Received: January 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Healthy
Interventions: Drug: Matching placebo (low dose)
Drug: BI 207127 NA (medium dose)
Drug: BI 207127 NA (low dose)
Drug: Matching placebo (medium dose)
Drug: BI 207127 NA (high dose)
Drug: Matching placebo (high dose)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
60 subjects were included (27 Chinese, 25 Japanese, and 8 Caucasian subjects). 24 Japanese and 24 Chinese subjects were randomised to 1 of 3 (rising) dose groups and received single oral doses of either 400mg, 800mg, or 1200mg of BI 207127 NA or of the respective placebo. Caucasian subjects were randomised to 1200 mg BI 207127 NA or placebo.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The decision to proceed to the next higher dose group was based upon the safety of the preceding dose group. Caucasian subjects were randomised to receive either placebo or 1200 mg BI 207127 NA; this dose group could be started independently from the results of dose escalation in the Asian subjects.

Reporting Groups
  Description
Placebo (Caucasian Subjects)

Caucasian subjects who received matching placebo.

Oral with 240 mL of water in fed condition.

1200 mg Deleobuvir (Caucasian Subjects)

Caucasian subjects who received 1200 mg Deleobuvir.

Oral with 240 mL of water in fed condition.

Placebo (Japanese Subjects)

Japanese subjects who received matching placebo.

Oral with 240 mL of water in fed condition.

400 mg Deleobuvir (Japanese Subjects)

Japanese subjects who received 400 mg Deleobuvir.

Oral with 240 mL of water in fed condition.

800 mg Deleobuvir (Japanese Subjects)

Japanese subjects who received 800 mg Deleobuvir.

Oral with 240 mL of water in fed condition.

1200mg Deleobuvir (Japanese Subjects)

Japanese subjects who received 1200 mg Deleobuvir.

Oral with 240 mL of water in fed condition.

Placebo (Chinese Subjects)

Chinese subjects who received matching placebo.

Oral with 240 mL of water in fed condition.

400 mg Deleobuvir (Chinese Subjects)

Chinese subjects who received 400 mg Deleobuvir.

Oral with 240 mL of water in fed condition.

800 mg Deleobuvir (Chinese Subjects)

Chinese subjects who received 800 mg Deleobuvir.

Oral with 240 mL of water in fed condition.

1200 mg Deleobuvir (Chinese Subjects)

Chinese subjects who received 1200 mg Deleobuvir.

Oral with 240 mL of water in fed condition.


Participant Flow:   Overall Study
    Placebo (Caucasian Subjects)   1200 mg Deleobuvir (Caucasian Subjects)   Placebo (Japanese Subjects)   400 mg Deleobuvir (Japanese Subjects)   800 mg Deleobuvir (Japanese Subjects)   1200mg Deleobuvir (Japanese Subjects)   Placebo (Chinese Subjects)   400 mg Deleobuvir (Chinese Subjects)   800 mg Deleobuvir (Chinese Subjects)   1200 mg Deleobuvir (Chinese Subjects)
STARTED   2   6   7 [1]   6   6   6   7 [2]   7 [3]   6   7 [3] 
COMPLETED   2   6   6   6   6   6   6   6   6   6 
NOT COMPLETED   0   0   1   0   0   0   1   1   0   1 
failed screening visit                0                0                1                0                0                0                1                1                0                1 
[1]

2 participants were treated together with each dose level of Deleobuvir.

1 subject was not treated.

[2]

2 participants treated together with each dose level of Deleobuvir.

1 subject was not treated.

[3] One subject was not treated.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The treated set (full analysis set according to ICH-E9): all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.

Reporting Groups
  Description
1200 mg Deleobuvir (Caucasian Subjects)

Caucasian subjects who received 1200 mg Deleobuvir.

Oral with 240 mL of water in fed condition.

Placebo (Caucasian Subjects)

Caucasian subjects who received matching placebo.

Oral with 240 mL of water in fed condition.

400 mg Deleobuvir (Japanese Subjects)

Japanese subjects who received 400 mg Deleobuvir.

Oral with 240 mL of water in fed condition.

800 mg Deleobuvir (Japanese Subjects)

Japanese subjects who received 800 mg Deleobuvir.

Oral with 240 mL of water in fed condition.

1200mg Deleobuvir (Japanese Subjects)

Japanese subjects who received 1200 mg Deleobuvir.

Oral with 240 mL of water in fed condition.

Placebo (Japanese Subjects)

Japanese subjects who received matching placebo.

Oral with 240 mL of water in fed condition.

400 mg Deleobuvir (Chinese Subjects)

Chinese subjects who received 400 mg Deleobuvir.

Oral with 240 mL of water in fed condition.

800 mg Deleobuvir (Chinese Subjects)

Chinese subjects who received 800 mg Deleobuvir.

Oral with 240 mL of water in fed condition.

1200 mg Deleobuvir (Chinese Subjects)

Chinese subjects who received 1200 mg Deleobuvir.

Oral with 240 mL of water in fed condition.

Placebo (Chinese Subjects)

Chinese subjects who received matching placebo.

Oral with 240 mL of water in fed condition.

Total Total of all reporting groups

Baseline Measures
   1200 mg Deleobuvir (Caucasian Subjects)   Placebo (Caucasian Subjects)   400 mg Deleobuvir (Japanese Subjects)   800 mg Deleobuvir (Japanese Subjects)   1200mg Deleobuvir (Japanese Subjects)   Placebo (Japanese Subjects)   400 mg Deleobuvir (Chinese Subjects)   800 mg Deleobuvir (Chinese Subjects)   1200 mg Deleobuvir (Chinese Subjects)   Placebo (Chinese Subjects)   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   2   6   6   6   6   6   6   6   6   56 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.3  (7.0)   31.0  (8.5)   28.8  (7.0)   28.2  (4.6)   23.7  (3.6)   29.2  (7.1)   24.7  (2.1)   26.0  (3.9)   23.7  (2.3)   23.0  (2.1)   26.4  (5.2) 
Gender 
[Units: Participants]
                     
Female   0   0   0   0   0   0   0   0   0   0   0 
Male   6   2   6   6   6   6   6   6   6   6   56 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Drug Related Adverse Events   [ Time Frame: From first administration of study drug (drug related AEs) until 14 days after end of trial visit, upto 17 days. ]

2.  Primary:   Number of Subjects With Adverse Events as Determined by Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG   [ Time Frame: From signing the informed consent (within 21 days before drug administration) until 14 days after end of trial visit, upto 38 days. ]

3.  Secondary:   AUC0-∞ of Deleobuvir   [ Time Frame: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h (hours) after drug administration ]

4.  Secondary:   Tmax of Deleobuvir   [ Time Frame: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration ]

5.  Secondary:   Cmax of Deleobuvir   [ Time Frame: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration ]

6.  Secondary:   AUC0-∞ of BI 208333 (Metabolite of Deleobuvir)   [ Time Frame: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration ]

7.  Secondary:   Tmax of BI 208333 (Metabolite of Deleobuvir)   [ Time Frame: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration ]

8.  Secondary:   Cmax of BI 208333 (Metabolite of Deleobuvir)   [ Time Frame: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration ]

9.  Secondary:   AUC0-∞ of CD 6168 (Metabolite of Deleobuvir)   [ Time Frame: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration ]

10.  Secondary:   Tmax of CD 6168 (Metabolite of Deleobuvir)   [ Time Frame: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration ]

11.  Secondary:   Cmax of CD 6168 (Metabolite of Deleobuvir)   [ Time Frame: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration ]

12.  Secondary:   AUC0-∞ of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)   [ Time Frame: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration ]

13.  Secondary:   Tmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)   [ Time Frame: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration ]

14.  Secondary:   Cmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)   [ Time Frame: -2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01347086     History of Changes
Other Study ID Numbers: 1241.8
Study First Received: May 3, 2011
Results First Received: January 21, 2016
Last Updated: March 16, 2016
Health Authority: Korea: Food and Drug Administration