VX-973 in Healthy Participants

Overseen By Medical Information

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Vertex Pharmaceuticals Incorporated

Disqualifiers: Febrile illness, Acute illness, others

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What is the purpose of this trial?

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of VX-973 in healthy participants.

Eligibility Criteria

This trial is for healthy adults with a BMI of 18.0 to 32.0 kg/m^2 and weight over 50 kg, who are not able to bear children, and have not smoked for at least three months. People can't join if they've been sick with a fever or other illness that hasn't cleared up within two weeks before starting the study, or have conditions that could affect how their body handles drugs.

Inclusion Criteria

Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m^2)

I weigh more than 50 kg.

I cannot become pregnant.

Exclusion Criteria

I have been healthy and fever-free for the last 14 days.

I have a condition that could affect how drugs work in my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose

Participants receive a single dose of VX-973 or placebo under fasted conditions

1 week

Multiple Ascending Dose

Participants receive multiple doses of VX-973 or placebo under fasted conditions

2-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• VX-973

Trial Overview The study tests VX-973 against a placebo in healthy participants to see how safe it is and how bodies react to different doses both one-time and over multiple doses. It looks at what the body does to the drug (pharmacokinetics) and what the drug does to the body (pharmacodynamics).

Participant Groups

Group I: Part B: Multiple Ascending Dose Experimental Treatment 1 Intervention

Participants will be randomized to receive multiple doses of VX-973 under fasted conditions.

Group II: Part A: Single Ascending Dose Experimental Treatment 1 Intervention

Participants will be randomized to receive a single dose of VX-973 under fasted conditions.

Group III: Placebo Part A Placebo Group 1 Intervention

Participants will be randomized to receive placebo matched to VX-973.

Group IV: Placebo Part B Placebo Group 1 Intervention

Participants will be randomized to receive placebo matched to VX-973.

Who Is Running the Clinical Trial?

Vertex Pharmaceuticals Incorporated

Lead Sponsor

Trials

267

Recruited

36,100+

Dr. David Altshuler

Vertex Pharmaceuticals Incorporated

Chief Medical Officer since 2020

MD, PhD

Dr. Reshma Kewalramani

Vertex Pharmaceuticals Incorporated

Chief Executive Officer since 2020

MD, trained in internal medicine and nephrology