A Phase 1 Dose Escalation Study to Evaluate Safety and Pharmacokinetics (PK) of VX-840 in Healthy Participants

NCT05324410 | Completed Phase 1 FDA Drug

• 1 other identifier: VX21-840-001
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

APOL1-mediated Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (4)

Part A: VX-840

EXPERIMENTAL

Participants will be randomized to receive single dose of one of different dose levels of VX-840.

Drug: VX-840

Part A: Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to VX-840.

Drug: Placebo

Part B: VX-840

EXPERIMENTAL

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

Part B: Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to VX-840.

Drug: Placebo

Interventions

VX-840 DRUG

Solution for oral administration.

Part A: VX-840; Part B: VX-840

Placebo DRUG

Placebo matched to VX-840 for oral administration.

Part A: Placebo; Part B: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• History of febrile illness or other acute illness within 14 days before the first dose of study drug
• Any condition possibly affecting drug absorption

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

ICON Lenexa

Lenexa, Kansas, 66219, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 12, 2022
• Study Start: April 7, 2022
• Primary Completion: November 7, 2022
• Study Completion: November 7, 2022
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)