A Phase 1, Randomized, Double-blind, Placebo-Controlled, Single- and Multiple-Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-440 Alone and in Combination with VX-661/Ivacaftor, and Bioavailability and Food Effect of VX-440 in Healthy Adult Subjects

A Phase 1, Randomized, Double-blind, Placebo-Controlled, Single- and Multiple-Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-440 Alone and in Combination with VX-661/Ivacaftor, and Bioavailability and Food Effect of VX-440 in Healthy Adult Subjects - A Study to Evaluate Safety and PK of VX-440 in Healthy Adult Subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43882

Enrollment

120

Registered

2015-10-20

Start date

2015-11-12

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

In all groups you will receive a single dose of VX-440 or placebo as an oral suspension. A placebo is a suspension or tablet without the active ingredient. The group that will be selected to continu

we call this *the study is blinded*. However, information on the administration of the study compound will be present in the clinical research center, in sealed envelopes, which can be opened in case

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male or female 18-55 y, incl. BMI 18.0 - 31.0, and a total body weight >50 kg

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 single oral ascending doses of VX 440 administered to healthy male and female subjects Part B To evaluate the safety and tolerability of multiple oral ascending doses of VX 440 administered for 14 days to healthy male and female subjects Part C To evaluate the safety and tolerability of multiple oral ascending doses of VX 440 administered in combination with VX 661/ivacaftor (triple combination [TC]) administered for 13 days to healthy male and female subjects Part D To evaluate the absolute bioavailability (BA) of oral VX 440 and the clearance of VX 440 administered as an isotopicallylabeled intravenous (IV) microdose to healthy male and female subjects	—

Measure

Time frame

Part A To evaluate the safety and tolerability of single oral ascending doses of VX 440 administered to healthy male and female subjects Part B To evaluate the safety and tolerability of multiple oral ascending doses of VX 440 administered for 14 days to healthy male and female subjects Part C To evaluate the safety and tolerability of multiple oral ascending doses of VX 440 administered in combination with VX 661/ivacaftor (triple combination [TC]) administered for 13 days to healthy male and female subjects Part D To evaluate the absolute bioavailability (BA) of oral VX 440 and the clearance of VX 440 administered as an isotopicallylabeled intravenous (IV) microdose to healthy male and female subjects

—

Secondary

Measure	Time frame
Part A To evaluate the PK of VX 440 after administration of single oral ascending doses of VX 440 to healthy male and female subjects To evaluate the relative BA of a tablet formulation of VX 440 relative to suspension in healthy male and female subjects To evaluate the effect of food on the PK of VX 440 when the tablet formulation is administered in fed (i.e., with a standard meal) relative to fasted conditions in healthy male and female subjects Part B To evaluate the PK of VX 440 after multiple oral ascending doses of VX 440 administered for 14 days to healthy male and female subjects Part C To evaluate the PK of VX 440 after multiple oral ascending doses of VX 440 in combination with VX 661 and ivacaftor administered for 13 days to healthy male and female subjects To evaluate the PK of ivacaftor and metabolites (M1 ivacaftor and M6 ivacaftor) and VX 661 and metabolites (M1 661 and M2 661) after single doses and after multiple oral doses in combination with VX 440 (TC) for 13 days to healthy male and female subjects	—

Measure

Time frame

Part A To evaluate the PK of VX 440 after administration of single oral ascending doses of VX 440 to healthy male and female subjects To evaluate the relative BA of a tablet formulation of VX 440 relative to suspension in healthy male and female subjects To evaluate the effect of food on the PK of VX 440 when the tablet formulation is administered in fed (i.e., with a standard meal) relative to fasted conditions in healthy male and female subjects Part B To evaluate the PK of VX 440 after multiple oral ascending doses of VX 440 administered for 14 days to healthy male and female subjects Part C To evaluate the PK of VX 440 after multiple oral ascending doses of VX 440 in combination with VX 661 and ivacaftor administered for 13 days to healthy male and female subjects To evaluate the PK of ivacaftor and metabolites (M1 ivacaftor and M6 ivacaftor) and VX 661 and metabolites (M1 661 and M2 661) after single doses and after multiple oral doses in combination with VX 440 (TC) for 13 days to healthy male and female subjects

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)