- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05324410
A Phase 1 Dose Escalation Study to Evaluate Safety and Pharmacokinetics (PK) of VX-840 in Healthy Participants
December 6, 2022 updated by: Vertex Pharmaceuticals Incorporated
A Phase I, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of VX-840 in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability, and PK of single and multiple ascending doses of VX-840 in healthy participants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.).
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Lenexa, Kansas, United States, 66219
- ICON Lenexa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- Female participants must be of non-childbearing potential
- 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
Other protocol defined Inclusion/Exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part A: VX-840
Participants will be randomized to receive single dose of one of different dose levels of VX-840.
|
Solution for oral administration.
|
Placebo Comparator: Part A: Placebo
Participants will receive placebo matched to VX-840.
|
Placebo matched to VX-840 for oral administration.
|
Experimental: Part B: VX-840
Participants will be randomized to receive multiple doses of one of different dose levels of VX-840.
The dose levels will be determined based on the data from Part A.
|
Solution for oral administration.
|
Placebo Comparator: Part B: Placebo
Participants will receive placebo matched to VX-840.
|
Placebo matched to VX-840 for oral administration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
From Day 1 up to Day 25
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Parts A and B: Plasma Concentration of VX-840 Over Time
Time Frame: From Day 1 up to Day 14
|
From Day 1 up to Day 14
|
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity [AUC(0 - inf)]
Time Frame: From Day 1 up to Day 14
|
From Day 1 up to Day 14
|
Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration [AUC(0-tlast)]
Time Frame: From Day 1 up to Day 14
|
From Day 1 up to Day 14
|
Part B: Amount of VX-840 Excreted in the Urine During the Dosing Interval (Ae)
Time Frame: From Day 1 up to Day 14
|
From Day 1 up to Day 14
|
Part B: Associated Renal Clearance (CLr) of VX-840
Time Frame: From Day 1 up to Day 14
|
From Day 1 up to Day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 7, 2022
Primary Completion (Actual)
November 7, 2022
Study Completion (Actual)
November 7, 2022
Study Registration Dates
First Submitted
April 5, 2022
First Submitted That Met QC Criteria
April 5, 2022
First Posted (Actual)
April 12, 2022
Study Record Updates
Last Update Posted (Estimate)
December 8, 2022
Last Update Submitted That Met QC Criteria
December 6, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VX21-840-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD 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
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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