A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-983 Followed by an Open-Label, Randomized, Crossover Study to Estimate the Effect of Steady State Administration of VX-983 on the Pharmacokinetics of a Single, Oral Dose of Midazolam in Healthy Adult Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-983 Followed by an Open-Label, Randomized, Crossover Study to Estimate the Effect of Steady State Administration of VX-983 on the Pharmacokinetics of a Single, Oral Dose of Midazolam in Healthy Adult Subjects - VX-983 FIH SAD, MAD, Midazolam DDI study in healthy volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37286

Enrollment

Registered

2012-12-21

Start date

2013-01-11

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

Cystic fibrosis

Interventions

Part A: single dose of VX 983 or placebo after 8 hours fasting period in the form of an oral suspension. Part b: multiple doses of VX 983 or placebo after 8 hours fasting period in the form of an or

treatment B: On Day 1 through 9 an oral dose of VX-983 will be administered. On Day 10 VX-983 is administered together with a single oral dose of 2 mg midazolam.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male and female subjects 18-55 yrs, inclusive BMI: 18.0-31.0 kg/m2, inclusive

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
Safety and tolerability will be based on the assessment of adverse events, clinically significant laboratory test results, 12-lead lectrocardiograms (ECGs), and vital signs.	—

Secondary

Measure	Time frame
Parts A and B: PK parameters will be calculated for VX-983 and its metabolites (if possible) from plasma and urine samples collected in this study Part C: PK parameters will be calculated for midazolam, 1-OHmidazolam, VX-983, and its metabolites (if possible) from plasma samples collected in this study	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)