A phase 1, two-part, randomized, open-label study to evaluate the relative bioavailability and food effect of test formulations of VX-152 and Ivacaftor in healthy subjects

A phase 1, two-part, randomized, open-label study to evaluate the relative bioavailability and food effect of test formulations of VX-152 and Ivacaftor in healthy subjects - Bioavailability and Food Effect Study of VX-152 and Ivacaftor

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43101

Enrollment

Registered

2016-03-30

Start date

2016-04-20

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: The study will consist of 1 period during which you will receive VX-152 5 times. VX-152 will be given orally as a suspension, a capsule and 2 tablet dosage forms. Part B

The study will consist of 1 period during which you will receive ivacaftor 3 times. Ivacaftor will be given as a tablet and a liquid filled capsule.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male and female volunteers 18-55 yrs, inclusive 18.0-31.0 kg/m2, inclusive non-smoking

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. The volunteers does not have a history of hemolysis and the blood analyses at screening are not indicative of G6PD deficiency or chronic hemolysis. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 56 days from the start of the study. In case of donating more than 0.5 liters of blood in the 56 days prior the start of this study.

Design outcomes

Primary

Measure	Time frame
Part A: To evaluate the relative bioavailability of 3 test formulations of VX-152 relative to suspension in healthy subjects Part B: To evaluate the relative bioavailability of a test formulation of ivacaftor relative to a tablet formulation in healthy subjects	—

Secondary

Measure	Time frame
Part A: - To evaluate the safety and tolerability of single doses of 3 test formulations of VX-152 administered to healthy subjects - To evaluate the effect of food on the pharmacokinetics (PK) of a test formulation of VX-152 when administered in fed relative to fasted conditions in healthy subjects Part B: - To evaluate the safety and tolerability of single doses of a test formulation of ivacaftor administered to healthy subjects - To evaluate the effect of food on the PK of a test formulation of ivacaftor when administered in fed relative to fasted conditions in healthy subjects	—

Measure

Time frame

Part A: - To evaluate the safety and tolerability of single doses of 3 test formulations of VX-152 administered to healthy subjects - To evaluate the effect of food on the pharmacokinetics (PK) of a test formulation of VX-152 when administered in fed relative to fasted conditions in healthy subjects Part B: - To evaluate the safety and tolerability of single doses of a test formulation of ivacaftor administered to healthy subjects - To evaluate the effect of food on the PK of a test formulation of ivacaftor when administered in fed relative to fasted conditions in healthy subjects

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)