A Phase 1, Randomized, Placebo- and Active-Controlled, Double-Blind, Parallel, Electrocardiogram Study to Evaluate the Effect of VX-661 on the QT/QTc Interval in Healthy Subjects

A Phase 1, Randomized, Placebo- and Active-Controlled, Double-Blind, Parallel, Electrocardiogram Study to Evaluate the Effect of VX-661 on the QT/QTc Interval in Healthy Subjects - VX15-661-010 QTc study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42529

Enrollment

130

Registered

2015-07-08

Start date

2015-07-21

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cystic fibrosis

Interventions

Part A: On Days 1 to 7 you will receive VX-661 or placebo once daily as oral tablets. A placebo is a tablet without the active ingredient. Whether you will receive VX-661 or placebo will be determin

we call this *the study is blinded*. However, information on the administration of the study compound will be present in the clinical research center, in sealed envelopes, which can be opened in ca

all will be administered as oral tablets. A placebo is a tablet without the active ingredient. Treatments are planned as follows: Day(s) Treatment A -1 VX-661 or matching placebo (2 tablets) 1 VX-6

as soon as the dose level is available, all subjects in Part B will be informed by an amendment to this form) 15 Moxifloxacin or matching placebo (1 tablet) Day(s) Treatment B -1 VX-661 or matching

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male or female 18-45 y, incl. BMI 18.0 - 30.0

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study

Design outcomes

Primary

Measure	Time frame
Part A: To evaluate the safety and tolerability of multiple ascending doses of VX-661 in healthy subjects. Part B: To evaluate the effects of therapeutic and supratherapeutic doses of VX-661 compared with placebo on the QTc interval in healthy subjects	—

Secondary

Measure	Time frame
Part A: To evaluate the PK of VX-661 and its metabolites, M1-661 and M2-661, following multiple ascending doses of VX-661 in healthy subjects Part B To evaluate assay sensitivity (i.e., to evaluate the effect of moxifloxacin on the QTc interval in healthy subjects) To assess the effects of VX-661 compared with placebo on other electrocardiogram (ECG) parameters (heart rate [HR], PR, and QRS intervals and T-wave morphology) in healthy subjects To determine the VX-661, M1-661, and M2-661 plasma concentration-effect relationship for the QTc interval and the magnitude of the relationship, if any exist To evaluate the PK of VX-661, M1-661, and M2-661 in healthy subjects To evaluate the safety and tolerability of VX-661 in healthy subjects	—

Measure

Time frame

Part A: To evaluate the PK of VX-661 and its metabolites, M1-661 and M2-661, following multiple ascending doses of VX-661 in healthy subjects Part B To evaluate assay sensitivity (i.e., to evaluate the effect of moxifloxacin on the QTc interval in healthy subjects) To assess the effects of VX-661 compared with placebo on other electrocardiogram (ECG) parameters (heart rate [HR], PR, and QRS intervals and T-wave morphology) in healthy subjects To determine the VX-661, M1-661, and M2-661 plasma concentration-effect relationship for the QTc interval and the magnitude of the relationship, if any exist To evaluate the PK of VX-661, M1-661, and M2-661 in healthy subjects To evaluate the safety and tolerability of VX-661 in healthy subjects

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)