Back to resultsA Phase 1 Dose Escalation Study of Oral VX-708 in Healthy Participants
Primary Purpose
Acute Pain
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
VX-708
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
Eligibility 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.
Sites / Locations
- MAC Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Part A: VX-708
Part A: Placebo
Part B: VX-708
Part B: Placebo
Arm Description
Participants will be randomized to receive a single dose of different dose levels of VX-708.
Participants will receive placebo matched to 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.
Participants will receive placebo matched to VX-708.
Outcomes
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)
Part B: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
Secondary Outcome Measures
Parts A and B: Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-708
Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test
Full Information
NCT ID
NCT05347394
First Posted
April 20, 2022
Last Updated
May 12, 2023
Sponsor
Vertex Pharmaceuticals Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT05347394
Brief Title
A Phase 1 Dose Escalation Study of Oral VX-708 in Healthy Participants
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 8, 2022 (Actual)
Primary Completion Date
April 14, 2023 (Actual)
Study Completion Date
April 14, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertex Pharmaceuticals Incorporated
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part A: VX-708
Arm Type
Experimental
Arm Description
Participants will be randomized to receive a single dose of different dose levels of VX-708.
Arm Title
Part A: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matched to VX-708.
Arm Title
Part B: VX-708
Arm Type
Experimental
Arm Description
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.
Arm Title
Part B: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matched to VX-708.
Intervention Type
Drug
Intervention Name(s)
VX-708
Intervention Description
Solution or suspension for oral administration.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matched to VX-708 for oral administration.
Primary Outcome Measure Information:
Title
Parts A and B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
From Day 1 up to Day 25
Title
Part B: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
Time Frame
From Day 1 up to Day 25
Secondary Outcome Measure Information:
Title
Parts A and B: Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-708
Time Frame
From Day 1 up to Day 25
Title
Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test
Time Frame
From Day 1 up to Day 11
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
MAC Clinical Research
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing
Learn more about this trial
A Phase 1 Dose Escalation Study of Oral VX-708 in Healthy Participants
We'll reach out to this number within 24 hrs