Evaluation of VX-659/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age
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|ClinicalTrials.gov Identifier: NCT03633526|
Recruitment Status : Terminated (Study discontinued after Part A due to Sponsor's discretion.)
First Posted : August 16, 2018
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and pharmacodynamic effect of VX-659, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF) subjects with F/F or F/MF genotypes.
The study was discontinued after completion of Part A due to Sponsor's discretion.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: VX-659/TEZ/IVA Drug: IVA||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-659/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age|
|Actual Study Start Date :||August 3, 2018|
|Actual Primary Completion Date :||January 18, 2019|
|Actual Study Completion Date :||January 18, 2019|
Participants who received VX-659 120 milligram (mg)/TEZ 50 mg/ IVA 75 mg as fixed-dose combination (FDC) in the morning and IVA 75 mg as a mono tablet in the evening in the triple combination (TC) treatment period.
VX-659/TEZ/IVA FDC tablet.
IVA mono tablet.
- Maximum Observed Concentration (Cmax) of VX-659, TEZ, and IVA [ Time Frame: Day 1 and Day 15 ]
- Observed Pre-Dose Concentration (Ctrough) of VX-659, TEZ, and IVA [ Time Frame: Day 8 and Day 15 ]
- Area Under the Concentration Versus Time Curve From Time 0 to 6 Hours (AUC0-6h) of VX-659, TEZ, and IVA [ Time Frame: Day 1 and Day 15 ]
- Maximum Observed Concentration (Cmax) of TEZ Metabolite (M1-TEZ), and IVA Metabolite (M1-IVA) [ Time Frame: Day 1 and Day 15 ]
- Observed Pre-Dose Concentration (Ctrough) of TEZ Metabolite (M1-TEZ), and IVA Metabolite (M1-IVA) [ Time Frame: Day 8 and Day 15 ]
- Area Under the Concentration Versus Time Curve From Time 0 to 6 Hours (AUC0-6h) of TEZ Metabolite (M1-TEZ), and IVA Metabolite (M1-IVA) [ Time Frame: Day 1 and Day 15 ]
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 6 weeks) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633526
|United States, Colorado|
|Children's Hospital Colorado|
|Aurora, Colorado, United States, 80045|
|United States, Illinois|
|Ann & Robert Lurie Children's Hospital of Chicago|
|Chicago, Illinois, United States, 60611|
|United States, Missouri|
|The Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|United States, North Carolina|
|Clinical Research of Charlotte|
|Charlotte, North Carolina, United States, 28277|
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|United States, Texas|
|Texas Children's Hospital|
|Houston, Texas, United States, 77030|