A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis
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|ClinicalTrials.gov Identifier: NCT03911713|
Recruitment Status : Active, not recruiting
First Posted : April 11, 2019
Last Update Posted : May 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: VX-561 Drug: IVA Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis|
|Actual Study Start Date :||April 17, 2019|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Subjects will be randomized to receive 1 of 4 dose levels of VX-561.
VX-561 tablets for oral administration.
Other Name: CTP-656
Placebo matched to IVA.
|Active Comparator: IVA||
150-mg film-coated tablet for oral administration.
Placebos matched to VX-561.
- Absolute change in percent predicted forced expiratory volume in 1 second (ppFEV1) [ Time Frame: From Baseline at Week 12 ]
- Absolute change in sweat chloride concentrations [ Time Frame: From Baseline at Week 12 ]
- Maximum observed concentration (Cmax) of VX-561, IVA, and relevant metabolites [ Time Frame: From Baseline up to Week 16 ]
- Area under the concentration versus time curve during a dosing interval (AUCtau) of VX-561, IVA, and relevant metabolites [ Time Frame: From Baseline up to Week 16 ]
- Observed pre-dose concentration (Ctrough) of VX-561, IVA, and relevant metabolites [ Time Frame: From Baseline up to Week 16 ]
- Safety and tolerability as assessed by number of subjects with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: From baseline up to Week 16 ]
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): NCT03911713