A phase 1, randomized, double-blind, placebo-controlled study evaluating the pharmacokinetics of capsule and tablet formulations of VX-150, including the effects of food and milk, the relative bioavailability of the tablet formulation, and the drug-drug interaction between VX-150 and Midazolam, in healthy adults

A phase 1, randomized, double-blind, placebo-controlled study evaluating the pharmacokinetics of capsule and tablet formulations of VX-150, including the effects of food and milk, the relative bioavailability of the tablet formulation, and the drug-drug interaction between VX-150 and Midazolam, in healthy adults - A study to evaluate pharmacokinetics of VX-150 in healthy adults

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45544

Enrollment

Registered

2017-01-26

Start date

2017-01-27

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

pijn pain

Interventions

Part A: Sequence Treatment Day 1 Treatment Day 6 Treatment Day 11 Treatment Day 16 1 750 mg once (fasted) 1250 mg once (fasted) 1250 mg once (fed) 1250 mg once (milk) 2 1250 mg once (fasted) 750 mg

Midazolam

pain

VX-150

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - healthy male or femaile 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 90 days before the start of this study or being a blood donor within 60 days from the start of the study. Blood donation (of approximately 1 pint [500 mL] or more) within 56 days before the first dose of study drug, or any significant loss of blood, as determined by the investigator, within 60 days before the first dose of study drug.

Design outcomes

Primary

Measure	Time frame
Plasma PK parameter estimates of VRT-1207355 and M5	—

Secondary

Measure	Time frame
- Plasma PK parameter estimates of midazolam and 1-hydroxy midazolam - Safety and tolerability based on the incidence and type of AEs, changes from baseline in clinically significant laboratory test results, ECGs (standard and continuous), and vital signs at designated visits	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)