A Phase 1 Dose Escalation Study of VX-973 in Healthy Adults

NCT05866055 | Completed Phase 1 FDA Drug

• 2 other identifiers: VX22-973-0012022-003301-30
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of VX-973 in healthy participants.

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

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

  From Day 1 up to Day 31

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

  From Day 1 up to Day 43

Secondary Outcomes (6)

• Part A: Maximum Observed Plasma Concentration (Cmax) of VX-973

  From Day 1 up to Day 30

• Part B: Maximum Observed Plasma Concentration (Cmax) of VX-973

  From Day 1 up to Day 43

• Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-973

  From Day 1 up to Day 30

• Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-973

  From Day 1 up to Day 43

• Part B: Maximum Observed Plasma Concentration (Cmax) of Midazolam in the Absence and Presence of VX-973

  Days -1 and 27: Pre-dose up to 24 hours Post Midazolam dose

Study Arms (4)

Part A: Single Ascending Dose

EXPERIMENTAL

Participants will be randomized to receive a single dose of VX-973 under fasted conditions.

Drug: VX-973

Part B: Multiple Ascending Dose

EXPERIMENTAL

Participants will be randomized to receive multiple doses of VX-973 under fasted conditions. The dose and frequency will be determined based on Part A. Midazolam is planned to be administered as single oral doses of 2 mg first alone on Day -1 and then co-administered with study drug on Day 27.

Drug: VX-973; Drug: Midazolam

Placebo Part A

PLACEBO COMPARATOR

Participants will be randomized to receive placebo matched to VX-973.

Drug: Placebo

Placebo Part B

PLACEBO COMPARATOR

Participants will be randomized to receive placebo matched to VX-973. Midazolam is planned to be administered as single oral doses of 2 mg first alone on Day -1 and then co-administered with placebo matched to VX-973 on Day 27.

Drug: Placebo; Drug: Midazolam

Interventions

VX-973 DRUG

Suspension for oral administration.

Part A: Single Ascending Dose; Part B: Multiple Ascending Dose

Placebo DRUG

Suspension for oral administration.

Placebo Part A; Placebo Part B

Midazolam DRUG

Syrup for oral administration.

Part B: Multiple Ascending Dose; Placebo Part B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

PAREXEL International

Harrow, United Kingdom

Location

MeSH Terms

Conditions

Pain

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 19, 2023
• Study Start: May 10, 2023
• Primary Completion: April 4, 2024
• Study Completion: April 4, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)