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Part A: Single Ascending Dose (SAD) for Pain

Phase 1

Recruiting

Research Sponsored by Vertex Pharmaceuticals Incorporated

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A total body weight of more than (>) 50 kg

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 up to day 43

Awards & highlights

Study Summary

This trial aims to determine if VX-993 is safe and well-tolerated at different doses in healthy individuals.

Who is the study for?

This trial is for healthy adults with a BMI of 18.0 to 32.0 and weighing over 50 kg, who are non-smokers or have quit smoking for at least 3 months. People can't join if they've been sick recently or have conditions that could affect how the body handles drugs.Check my eligibility

What is being tested?

The study tests VX-993's safety and how it affects the body at different doses compared to a placebo (a substance with no active drug) in healthy participants to understand its potential as a pain medication.See study design

What are the potential side effects?

Since this is an early-phase trial for VX-993, specific side effects aren't listed yet but generally may include reactions where the drug is administered, changes in appetite, sleep disturbances, mood changes, or other unexpected health concerns.

Eligibility Criteria

Inclusion Criteria

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

Select...

I weigh more than 50 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 up to day 43

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 up to day 43

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to day 43 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: 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 Adverse Events (AEs) and Serious Adverse Events (SAEs)

Secondary outcome measures

Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-993

Part A: Maximum Observed Plasma Concentration (Cmax) of VX-993

Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-993

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B: Multiple Ascending Dose (MAD)Experimental Treatment1 Intervention

Participants will be randomized to receive multiple doses of different dose levels of VX-993. The dose levels will be determined based on the data from Part A.

Group II: Part A: Single Ascending Dose (SAD)Experimental Treatment1 Intervention

Participants will be randomized to receive a single dose of different dose levels of VX-993.

Group III: Part A: PlaceboPlacebo Group1 Intervention

Participants will be randomized to receive placebo matched to VX-993.

Group IV: Part B: PlaceboPlacebo Group1 Intervention

Participants will be randomized to receive placebo matched to VX-993.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VX-993

2022

Completed Phase 1

~70

0 / 1Eligibility criteria met

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

243 Previous Clinical Trials

32,348 Total Patients Enrolled

14 Trials studying Pain

1,050 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.

Is the recruitment phase for this medical study currently ongoing?

"Indeed, according to the details on clinicaltrials.gov, this trial is currently in search of eligible patients for enrollment. The initial posting took place on January 4th, 2024 and the most recent update occurred on January 17th, 2024. A total of 40 participants are being sought at a single designated location."

Answered by AI

What level of risk does Part A: Single Ascending Dose (SAD) pose to individuals?

"As a Phase 1 trial, Part A: Single Ascending Dose (SAD) has limited data supporting both safety and efficacy. Therefore, our team at Power rates the safety of this stage as 1 on a scale from 1 to 3."

Answered by AI

What is the current total number of participants being recruited for this clinical study?

"Indeed, the data available on clinicaltrials.gov confirms that this trial is actively seeking participants. The initial posting date was January 4th, 2024, and it received its most recent update on January 17th, 2024. The study aims to recruit a total of 40 patients from a single site."

Answered by AI

Does this research project include individuals aged 85 and above in its patient recruitment process?

"To be eligible for this clinical trial, patients must fall within the age range of 18 to 55. It should also be noted that there are a total of 59 ongoing trials specifically designed for individuals under the age of 18 and an additional 274 trials targeted towards patients over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics, of VX-993

2024. "A Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics, of VX-993". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06226454.