A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of VX-407 in Healthy Participants

NCT06345755
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Participants
159
clinicaltrials.gov
Lead sponsor
Vertex Pharmaceuticals Incorporated
clinicaltrials.gov
Start date
2024-04-17
clinicaltrials.gov
Number of sites
2
clinicaltrials.gov

Summary
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic parameters of VX-407 in healthy participants.
clinicaltrials.gov
Short title
A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of VX-407 in Healthy Participants
clinicaltrials.gov
Official title
A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of VX-407 in Healthy Subjects
clinicaltrials.gov

Control arm
Placebo
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2025-06-13
clinicaltrials.gov
First posted
2024-04-03
clinicaltrials.gov
Registry last updated
2025-07-14
clinicaltrials.gov
Primary completion date
2025-01-27
clinicaltrials.gov
Start date
2024-04-17
clinicaltrials.gov

Actual participants
159
clinicaltrials.gov
Participants
159
clinicaltrials.gov
Participant count basis
Actual
clinicaltrials.gov
Protocol amendments
4
clinicaltrials.gov
Number of sites
2
clinicaltrials.gov

Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Vertex Pharmaceuticals Incorporated
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06345755
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06345755
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Sequential
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Timeframe: From Enrollment up to Day 10

  2. Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Timeframe: From Enrollment up to Day 23

  1. Part A: Maximum Observed Plasma Concentration (Cmax) of VX-407

    Timeframe: From Day 1 up to Day 6

  2. Part B: Maximum Observed Plasma Concentration (Cmax) of VX-407

    Timeframe: Days 1, 7, and 14

  3. Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-407

    Timeframe: From Day 1 up to Day 6

  4. Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-407

    Timeframe: Days 1, 7, and 14

  5. Part C: Area Under the Concentration Versus Time Curve (AUC) of MDZ in Absence and Presence of VX-407

    Timeframe: On Day 1, and Day 15

  6. Part C: Maximum Observed Plasma Concentration (Cmax) of MDZ in Absence and Presence of VX-407

    Timeframe: On Day 1, and Day 15

  7. Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Timeframe: From Enrollment up to Day 24

  8. Part D: Maximum Observed Plasma Concentration (Cmax) of VX-407 Tablet Formulation (test) compared to a Suspension Formulation (reference) Under Fasted Conditions

    Timeframe: Days 1, 7, and 13

  9. Part D: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407 Under Fasted Conditions

    Timeframe: Days 1, 7, and 13

  10. Part D: Maximum Observed Plasma Concentration (Cmax) of VX-407 Tablet Formulation Under Fed versus Fasted State

    Timeframe: Days 1, 7, and 13

  11. Part D: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407 Tablet Formulation Under Fed versus Fasted State

    Timeframe: Days 1, 7, and 13

  12. Part D: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Timeframe: From Enrollment up to Day 22

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
55 Years
Healthy volunteers
Yes

Key Inclusion Criteria:

  • Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m^2)
  • A total body weight of greater than (>) 50 kg
  • Nonsmoker or ex-smoker for at least 3 months before screening

Key Exclusion Criteria:

  • History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
  • Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.

Sources for eligibility
clinicaltrials.gov

  • ICON LenexaLenexa, United States
  • Altasciences MontrealMontreal, Canada
Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)

Targets (16)