A Phase 1, Randomized, Placebo- and Active-Controlled, Double-Blind, 4-Period Crossover ECG Study to Evaluate the Effect of VX 509 on QT/QTc Interval in Healthy Adult Subjects

A Phase 1, Randomized, Placebo- and Active-Controlled, Double-Blind, 4-Period Crossover ECG Study to Evaluate the Effect of VX 509 on QT/QTc Interval in Healthy Adult Subjects - VX-509 QTc study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37134

Enrollment

Registered

2012-08-01

Start date

2012-08-15

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

autoimmune disorders Rheumatoid arthritis

Interventions

Part A: 750 mg qd VX-509 or placebo as 15 tablets for 7 days. Part B: The subjects will receive each one of the described treatments during one of the periods in a random order. Treatment A (Therap

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male and female subjects 18-55 yrs, inclusive (part A) 18-45 yrs, inclusive (part B) BMI: 18.0-31.0 kg/m2, inclusive non-smoking

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 doses of 750 mg qd of VX-509 in healthy subjects. Part B: - To evaluate the effect of 200 mg qd (therapeutic) and 600 or 750 mg qd (supratherapeutic dose; to be determined from Part A) of VX-509, versus placebo on the QT/QTc interval in healthy subjects.	—

Secondary

Measure	Time frame
Part A: - To evaluate the pharmacokinetics (PK) in healthy subjects receiving multiple doses of 750 mg qd of VX-509 for 7 days Part B: - To assess the effect of 200 mg qd (therapeutic dose) and 600 or 750 mg qd (supratherapeutic dose; to be determined from Part A) of VX-509, versus placebo on non-QT interval electrocardiogram (ECG) parameters (heart rate [HR], RR, PR and QRS interval) in healthy subjects. - To assess the effects of a positive control (a single, oral dose of 400 mg of moxifloxacin) on the QTc interval in healthy subjects, as an indicator of study sensitivity. - To determine the VX-509 plasma concentration-effect relationship for the QT/QTc interval and the magnitude of the relationship, if any exist. - To evaluate the PK of VX-509 in healthy subjects. - To evaluate the safety and tolerability of therapeutic and supratherapeutic systemic exposure of VX-509 in healthy subjects.	—

Measure

Time frame

Part A: - To evaluate the pharmacokinetics (PK) in healthy subjects receiving multiple doses of 750 mg qd of VX-509 for 7 days Part B: - To assess the effect of 200 mg qd (therapeutic dose) and 600 or 750 mg qd (supratherapeutic dose; to be determined from Part A) of VX-509, versus placebo on non-QT interval electrocardiogram (ECG) parameters (heart rate [HR], RR, PR and QRS interval) in healthy subjects. - To assess the effects of a positive control (a single, oral dose of 400 mg of moxifloxacin) on the QTc interval in healthy subjects, as an indicator of study sensitivity. - To determine the VX-509 plasma concentration-effect relationship for the QT/QTc interval and the magnitude of the relationship, if any exist. - To evaluate the PK of VX-509 in healthy subjects. - To evaluate the safety and tolerability of therapeutic and supratherapeutic systemic exposure of VX-509 in healthy subjects.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)