A phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study evaluating safety and pharmacokinetics of VX-150 including an assessment of the effect of food on the pharmacokinetics of VX-150 in healthy adult subjects.

A phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study evaluating safety and pharmacokinetics of VX-150 including an assessment of the effect of food on the pharmacokinetics of VX-150 in healthy adult subjects. - VX-150 SAD/MAD/FE Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41908

Enrollment

Registered

2015-01-26

Start date

2015-01-28

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

Group 1: 1 x 25 mg VX 150 or placebo, once 2: 1 x X mg VX 150 or placebo, once 3: 1 x X mg VX 150 or placebo, once 4/7: 1 x X mg VX 150 or placebo en 3 x X mg VX 150 once 5: 1 x X mg VX 150 or pla

Pain

VX-150

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Healthy male or female volunteers 18 and 55 years of age, inclusive BMI 18.0 - 31.0 kilograms/meter2

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. 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 of single doses of VX-150. Safety and tolerability of multiple doses of VX-150.	—

Secondary

Measure	Time frame
n.a.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)