RECRUITINGPhase 1

Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of VX-581.

Sponsor

Vertex Pharmaceuticals Incorporated

Enrollment

128 participants

Sites

1 locations

Start Date

December 2025

Completion

November 2026

Cystic FibrosisVX-581Placebo

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

128

participants

Sites

locations

Duration

11 months

total trial span

Rate

pts/month needed

Dec 2025Month 6 of 11Nov 2026

55% of trial timeline elapsed5 months to primary endpoint

At 1 sites, each site needs to enroll approximately 12.0 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

From Day -1 up to Day 8

Part 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 17

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Fetching protocol from ClinicalTrials.gov…

RECRUITINGPhase 1

Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of VX-581.

Sponsor

Vertex Pharmaceuticals Incorporated

Enrollment

128 participants

Sites

1 locations

Start Date

December 2025

Completion

November 2026

Cystic FibrosisVX-581Placebo

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

128

participants

Sites

locations

Duration

11 months

total trial span

Rate

pts/month needed

Dec 2025Month 6 of 11Nov 2026

55% of trial timeline elapsed5 months to primary endpoint

At 1 sites, each site needs to enroll approximately 12.0 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

From Day -1 up to Day 8

Part 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 17

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

all

Healthy Volunteers

Yes

View full criteria

Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2)
* A total body weight of more than (\>) 50 kg
* Male and Female participants of non-childbearing potential

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.

Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (1)