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Part A: VX-708 (Cohort A1-A3) for Pain

Phase 1
Waitlist Available
Research Sponsored by Vertex Pharmaceuticals Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 up to day 32
Awards & highlights

Study Summary

The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple ascending doses of VX-708 in healthy participants

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to day 32
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to day 32 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Continuous Pulse Oximetry Monitoring as assessed by oxygen saturation for Cohort A4
Part A: Infusion Nurses Society (INS) Visual Infusion Phlebitis (VIP) Score Monitoring
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
+2 more
Secondary outcome measures
Midazolam
Part A: Area Under the Plasma Concentration Versus Time Curve from the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-708
Part B: Infusion Nurses Society (INS) Visual Infusion Phlebitis (VIP) Score
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B: VX-708 With ItraconazoleExperimental Treatment2 Interventions
Participants will receive a single dose of VX-708 in treatment period 1, followed by itraconazole, which will be dosed daily with a single dose of VX-708 administered in treatment period 2 under fasting conditions. A washout period of 6 days will be maintained between the 2 treatment periods.
Group II: Part A: VX-708 (Cohort A1-A3)Experimental Treatment1 Intervention
Participants will receive multiple doses of one of different dose levels of VX-708 under fasting condition.
Group III: Part A: Midazolam With or Without VX-708 (Cohort A4)Experimental Treatment2 Interventions
Participants will receive a single dose of Midazolam with or without VX-708 under fasting condition.
Group IV: Part A: PlaceboPlacebo Group1 Intervention
Participants will receive placebo matched to VX-708.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VX-708
2022
Completed Phase 1
~170
Itraconazole
2017
Completed Phase 2
~780
Midazolam
2018
Completed Phase 4
~1920

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
240 Previous Clinical Trials
32,154 Total Patients Enrolled
13 Trials studying Pain
1,002 Patients Enrolled for Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must participants meet to qualify for this medical trial?

"This medical trial is taking on 54 participants aged 18 to 55 suffering from pain. The following prerequisites must be met in order for an individual to qualify: BMI of 18.0 - 32.0 kg/m^2, gender not capable of childbearing, and total body weight higher than 50kg."

Answered by AI

Are there opportunities for individuals to participate in this trial at present?

"Affirmative. According to data on clinicaltrials.gov, the trial which was initially posted on 17th September 2022 is recruiting participants at this moment in time. 54 volunteers are needed from a single medical site for the research endeavor that was last modified 7 October 2022."

Answered by AI

What risks might be associated with taking Part A: Midazolam With or Without VX-708 (Cohort A4)?

"Our analysis at Power awarded Part A: Midazolam With or Without VX-708 (Cohort A4) a score of 1 due to the fact that this is merely a Phase 1 trial, which implies limited data confirming its safety and efficacy."

Answered by AI

Are individuals aged 80 or younger able to participate in this medical experiment?

"This clinical trial seeks participants aged 18 years old or older and 55 years old or younger."

Answered by AI

To what extent is participation sought in this medical experiment?

"Indeed, the clinicaltrials.gov database has evidence that this research project is actively recruiting participants. It was first posted on September 17th 2022 and was last modified a month later. The investigators are looking for 54 individuals at one site specifically."

Answered by AI
~26 spots leftby Mar 2025