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Trial record 17 of 17 for:    "Allergic bronchopulmonary aspergillosis"

Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis Patients

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ClinicalTrials.gov Identifier: NCT02190604
Recruitment Status : Terminated
First Posted : July 15, 2014
Results First Posted : July 19, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Cystic Fibrosis
Interventions: Drug: Placebo
Drug: QBW251

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
For Cohort 6 continuing into the food effect part of the study the subjects remained on the same treatment assignment that was required during the fed state. Therefore no randomization f the subject occurred during the food effect arm. Only 5 of the 6 subjects went into the fed cohort.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In parts 1 and 2, participants (Healthy Volunteers) were randomized 3:1 to receive QBW251X or placebo. In part 3, participants (cystic fibrosis (CF) patients) were randomized 3:1 to receive QBW251X or placebo.

Reporting Groups
  Description
Part 1 Cohort 1: QBW251 Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
Part 1 Cohort 2: QBW251 Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
Part 1 Cohort 3: QBW251 Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
Part 1 Cohort 4: QBW251 Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
Part 1 Cohort 5: QBW251 Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
Part 1 Cohort 6: QBW251 (Fasting/Fed), Same Subjects Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
Part 1 Cohort 7: QBW251 Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
Part 1 Cohort 8: QBW251 Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
Part 1 Placebo Placebo to QBW251 in all cohorts of part 1 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
Part 2 Cohort 1: QBW251 Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
Part 2 Cohort 2: QBW251 Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
Part 2 Cohort 3: QBW251 Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
Part 2 Cohort 4: QBW251 Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
Part 2 Cohort 5: QBW251 Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
Part 2 Placebo Placebo to QBW251 in all cohorts of part 2 in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
Part 3 Cohort 1: QBW251 150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
Part 3 Cohort 2: QBW251 450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
Part 3 Cohort 3: QBW251 450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
Part 3 Placebo Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.

Participant Flow for 2 periods

Period 1:   Part 1 and 2 (Healthy Volunteers)
    Part 1 Cohort 1: QBW251   Part 1 Cohort 2: QBW251   Part 1 Cohort 3: QBW251   Part 1 Cohort 4: QBW251   Part 1 Cohort 5: QBW251   Part 1 Cohort 6: QBW251 (Fasting/Fed), Same Subjects   Part 1 Cohort 7: QBW251   Part 1 Cohort 8: QBW251   Part 1 Placebo   Part 2 Cohort 1: QBW251   Part 2 Cohort 2: QBW251   Part 2 Cohort 3: QBW251   Part 2 Cohort 4: QBW251   Part 2 Cohort 5: QBW251   Part 2 Placebo   Part 3 Cohort 1: QBW251   Part 3 Cohort 2: QBW251   Part 3 Cohort 3: QBW251   Part 3 Placebo
STARTED   6   6   6   6   6   6   6   6   16   6   6   6   6   6   10   0   0   0   0 
COMPLETED   6   6   6   6   6   6   6   6   16   6   6   6   6   5   8   0   0   0   0 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0   0   0   0   1   2   0   0   0   0 
Adverse Event                0                0                0                0                0                0                0                0                0                0                0                0                0                0                2                0                0                0                0 
Lost to Follow-up                0                0                0                0                0                0                0                0                0                0                0                0                0                1                0                0                0                0                0 

Period 2:   Part 3 (Patients)
    Part 1 Cohort 1: QBW251   Part 1 Cohort 2: QBW251   Part 1 Cohort 3: QBW251   Part 1 Cohort 4: QBW251   Part 1 Cohort 5: QBW251   Part 1 Cohort 6: QBW251 (Fasting/Fed), Same Subjects   Part 1 Cohort 7: QBW251   Part 1 Cohort 8: QBW251   Part 1 Placebo   Part 2 Cohort 1: QBW251   Part 2 Cohort 2: QBW251   Part 2 Cohort 3: QBW251   Part 2 Cohort 4: QBW251   Part 2 Cohort 5: QBW251   Part 2 Placebo   Part 3 Cohort 1: QBW251   Part 3 Cohort 2: QBW251   Part 3 Cohort 3: QBW251   Part 3 Placebo
STARTED   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   6   12   19   12 
COMPLETED   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   6   12   19   12 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Part 1 Cohort 1: QBW251 Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
Part 1 Cohort 2: QBW251 Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
Part 1 Cohort 3: QBW251 Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
Part 1 Cohort 4: QBW251 Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
Part 1 Cohort 6: QBW251 Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
Part 1 Cohort 6: QBW251 (Fastin / Fed), Same Subjects Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
Part 1 Cohort 7: QBW251 Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
Part 1 Cohort 8: QBW251 Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
Part 1 Placebo Placebo to QBW251 in all cohorts of part 1 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).
Part 2 Cohort 1: QBW251 Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
Part 2 Cohort 2: QBW251 Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
Part 2 Cohort 3: QBW251 Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
Part 2 Cohort 4: QBW251 Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
Part 2 Cohort 5: QBW251 Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
Part 2 Placebo Placebo to QBW251 in all cohorts of part 2 in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).
Part 3 Cohort 1: QBW251 150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
Part 3 Cohort 2: QBW251 450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
Part 3 Cohort 3: QBW251 450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
Part 3 Placebo Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.
Total Total of all reporting groups

Baseline Measures
   Part 1 Cohort 1: QBW251   Part 1 Cohort 2: QBW251   Part 1 Cohort 3: QBW251   Part 1 Cohort 4: QBW251   Part 1 Cohort 6: QBW251   Part 1 Cohort 6: QBW251 (Fastin / Fed), Same Subjects   Part 1 Cohort 7: QBW251   Part 1 Cohort 8: QBW251   Part 1 Placebo   Part 2 Cohort 1: QBW251   Part 2 Cohort 2: QBW251   Part 2 Cohort 3: QBW251   Part 2 Cohort 4: QBW251   Part 2 Cohort 5: QBW251   Part 2 Placebo   Part 3 Cohort 1: QBW251   Part 3 Cohort 2: QBW251   Part 3 Cohort 3: QBW251   Part 3 Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   6   6   6   6   6   6   16   6   6   6   6   6   10   6   12   19   12   153 
Age [1] [2] [3] 
[Units: Years]
Mean (Standard Deviation)
                                       
Part 1, HV (n= 64)   36.3  (8.69)   35  (14.25)   43.5  (3.39)   33.3  (9.61)   44.2  (8.23)   43.6  (9.07)   28.2  (9.28)   33.2  (9.47)   30.3  (9.18)   NA [1]   NA [1]   NA [1]   NA [1]   NA [1]   NA [1]   NA [1]   NA [1]   NA [1]   NA [1]   34.4  (9.92) 
Part 2, HV (n=40)   NA [2]   NA [2]   NA [2]   NA [2]   NA [2]   NA [2]   NA [2]   NA [2]   NA [2]   30.3  (5.13)   30.5  (5.89)   29.2  (11.62)   31.7  (13.22)   27.8  (5)   29  (6.22)   NA [2]   NA [2]   NA [2]   NA [2]   29.7  (7.82) 
Part 3, CF patients (n=49)   NA [3]   NA [3]   NA [3]   NA [3]   NA [3]   NA [3]   NA [3]   NA [3]   NA [3]   NA [3]   NA [3]   NA [3]   NA [3]   NA [3]   NA [3]   39.3  (5.47)   32.7  (13.77)   27  (5.44)   27.9  (6.37)   30.1  (9.18) 
[1] This row is for Part 1 HV
[2] This row is for Part 2 HV
[3] This row is for Part 3 HV
Sex: Female, Male 
[Units: Participants]
Count of Participants
                                       
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1  16.7%      5  41.7%      9  47.4%      4  33.3%      19  12.4% 
Male      6 100.0%      6 100.0%      6 100.0%      6 100.0%      6 100.0%      6 100.0%      6 100.0%      6 100.0%      16 100.0%      6 100.0%      6 100.0%      6 100.0%      6 100.0%      6 100.0%      10 100.0%      5  83.3%      7  58.3%      10  52.6%      8  66.7%      134  87.6% 


  Outcome Measures

1.  Primary:   Part 1 and 2:Number of Participants (Healthy Volunteers) With Reported Adverse Events Receiving QBW251   [ Time Frame: Day 1 to Day 36 ]

2.  Primary:   Part 3: Change in Lung Clearance Index (LCI) From Baseline to Day 15   [ Time Frame: Baseline and Day 15 ]

3.  Primary:   Part 3: Number of Participants (Patients) With Reported Adverse Events Receiving QBW251   [ Time Frame: Day 1 to Day 56 ]

4.  Secondary:   Part 3:Change in Forced Expiratory Volume in 1 Second (FEV1) at Day 15   [ Time Frame: Baseline and Day 15 ]

5.  Secondary:   Part 3: Change in Cystic Fibrosis Questionnaire-Revised Reported Outcomes   [ Time Frame: Baseline and Day 14 ]

6.  Secondary:   Part 1: AUC0-t in Healthy Volunteers   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 2-5) ]

7.  Secondary:   Part 1: Maximum Concentration (Cmax) in Healthy Volunteers   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5) ]

8.  Secondary:   Part 1: Time to Maximum Concentration (Tmax) in Healthy Volunteers   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5) ]

9.  Secondary:   Part 1: T1/2 in Healthy Volunteers   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5) ]

10.  Secondary:   Part 1: AUCinf in Healthy Volunteers   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5) ]

11.  Secondary:   Part 1: CL/F in Healthy Volunteers   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5) ]

12.  Secondary:   Part 1: Vz/F in Healthy Volunteers   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5) ]

13.  Secondary:   Part 2: AUCtau in Healthy Volunteers   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed) ]

14.  Secondary:   Part 2: Maximum Concentration (Cmax) in Healthy Volunteers   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed) ]

15.  Secondary:   Part 2: Time to Maximum Concentration (Tmax) in Healthy Volunteers   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed) ]

16.  Secondary:   Part 2: AUC0-t   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed) ]

17.  Secondary:   Part 2: Cav in Healthy Volunteers   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed) ]

18.  Secondary:   Part 2: CL/F in Healthy Volunteers   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed) ]

19.  Secondary:   Part 2: Vz/F in Healthy Volunteers   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed) ]

20.  Secondary:   Part 2: Racc in Healthy Volunteers   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 - 14; ( If B ID dosing, 12 hours samples will be pre-dosed) ]

21.  Secondary:   Part 2: T1/2 in Healthy Volunteers   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed) ]

22.  Secondary:   Part 3: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of QBW251 in CF Patients   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14 ]

23.  Secondary:   Part 3: Plasma Concentration at the Last Quantifiable Time Point (Clast) of QBW251 in CF Patients   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day2 ]

24.  Secondary:   Part 3: Maximum Concentration (Cmax) in CF Patients   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14 ]

25.  Secondary:   Part 3: Tlast in CF Patients   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14 ]

26.  Secondary:   Part 3: Time to Maximum Concentration (Tmax)   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14 ]

27.  Secondary:   Part 2: Ae0-t in Healthy Volunteers   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 ]

28.  Secondary:   Part 2: CLr in Healthy Volunteers   [ Time Frame: Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1; Day 14 was calculated as urine was only collected up to 12 hours on Day 1 thus CLr cannot be calculated. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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: Study Director
Organization: Novartis
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02190604     History of Changes
Other Study ID Numbers: CQBW251X2101
2011-005085-37 ( EudraCT Number )
First Submitted: July 11, 2014
First Posted: July 15, 2014
Results First Submitted: November 23, 2016
Results First Posted: July 19, 2017
Last Update Posted: July 19, 2017