Acute Pain Clinical Trial
Official title:
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose Escalation Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Oral VX-708 in Healthy Subjects
Verified date | May 2023 |
Source | Vertex Pharmaceuticals Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | April 14, 2023 |
Est. primary completion date | April 14, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | MAC Clinical Research | Manchester |
Lead Sponsor | Collaborator |
---|---|
Vertex Pharmaceuticals Incorporated |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ||
Primary | 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 | 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 | ||
Secondary | Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test | From Day 1 up to Day 11 |
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