A Phase 1 Dose Escalation Study of Oral VX-708 in Healthy Participants
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of VX-708 in healthy participants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part A: VX-708 Participants will be randomized to receive a single dose of different dose levels of VX-708. |
Drug: VX-708
Solution or suspension for oral administration.
|
| Placebo Comparator: Part A: Placebo Participants will receive placebo matched to VX-708. |
Drug: Placebo
Placebo matched to VX-708 for oral administration.
|
| Experimental: Part B: VX-708 Participants will be randomized to receive multiple doses of different dose levels of VX-708. The dose levels will be determined based on the data from Part A. |
Drug: VX-708
Solution or suspension for oral administration.
|
| Placebo Comparator: Part B: Placebo Participants will receive placebo matched to VX-708. |
Drug: Placebo
Placebo matched to VX-708 for oral administration.
|
Outcome Measures
Primary Outcome Measures
- Parts A and 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 25]
- Part B: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses [From Day 1 up to Day 25]
Secondary Outcome Measures
- Parts A and B: Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-708 [From Day 1 up to Day 25]
- Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test [From Day 1 up to Day 11]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
Male and female of non-childbearing potential are eligible
-
Body mass index (BMI) of 18.0 to 32.0 kilograms per meter square (kg/m^2)
-
A total body weight greater than (>) 50 kg
Key Exclusion Criteria:
-
History of febrile illness or other acute illness within 14 days before the first dose of study drug
-
Any condition possibly affecting drug absorption, distribution, metabolism, or excretion
-
History of cardiac dysrhythmias
Other protocol defined Inclusion/Exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MAC Clinical Research | Manchester | United Kingdom |
Sponsors and Collaborators
- Vertex Pharmaceuticals Incorporated
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VX21-708-002
- 2021-005559-35