A Phase 1 Dose Escalation Study to Evaluate Safety and Pharmacokinetics (PK) of VX-840 in Healthy Participants
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
| 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. |
Drug: VX-840
Solution for oral administration.
|
| Placebo Comparator: Part A: Placebo Participants will receive placebo matched to VX-840. |
Drug: Placebo
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. |
Drug: VX-840
Solution for oral administration.
|
| Placebo Comparator: Part B: Placebo Participants will receive placebo matched to VX-840. |
Drug: Placebo
Placebo matched to VX-840 for oral administration.
|
Outcome Measures
Primary Outcome Measures
- Parts A and 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 25]
Secondary Outcome Measures
- Parts A and B: Plasma Concentration of VX-840 Over Time [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)] [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)] [From Day 1 up to Day 14]
- Part B: Amount of VX-840 Excreted in the Urine During the Dosing Interval (Ae) [From Day 1 up to Day 14]
- Part B: Associated Renal Clearance (CLr) of VX-840 [From Day 1 up to Day 14]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ICON Lenexa | Lenexa | Kansas | United States | 66219 |
Sponsors and Collaborators
- Vertex Pharmaceuticals Incorporated
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VX21-840-001