A Phase 1 Dose Escalation Study of VX-708 in Healthy Participants
NCT05518734 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2023-03-30
Summary
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple ascending doses of VX-708 in healthy participants
Conditions
Interventions
- DRUG
-
VX-708
Solution for intravenous (IV) administration.
- DRUG
-
Itraconazole
Solution for oral administration.
- DRUG
-
Midazolam
Solution for oral administration.
- DRUG
-
Placebo matched to VX-708 for IV administration.
Sponsors & Collaborators
-
Vertex Pharmaceuticals Incorporated
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-09-17
- Primary Completion
- 2023-03-07
- Completion
- 2023-03-07
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics, of VX-993
NCT06226454 ·Status: COMPLETED ·Phase: PHASE1
-
Assessment of the Safety, Tolerability and Pharmacokinetics of AV078 in Healthy Volunteers
NCT06205381 ·Status: COMPLETED ·Phase: PHASE1
-
Phase I Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Injection of SHR-2173 in Healthy Subjects
NCT06995001 ·Status: COMPLETED ·Phase: PHASE1
-
VNRX-5024 Safety and PK in Healthy Adult Volunteers
NCT04314206 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SR1375
NCT05026008 ·Status: COMPLETED ·Phase: PHASE1
-
VNRX-7145 SAD/MAD Safety and PK in Healthy Adult Volunteers
NCT04243863 ·Status: COMPLETED ·Phase: PHASE1
-
A PHASE I, RANDOMIZED, PLACEBO-CONTROLLED, SINGLE DOSE ESCALATION STUDY TO INVESTIGATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF SHR0534 IN HEALTHY VOLUNTEERS
NCT02749097 ·Status: COMPLETED ·Phase: PHASE1
-
VNRX-5133 SAD/MAD Safety and PK in Healthy Adult Volunteers
NCT02955459 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Effect of VX-548 on the QT/QTc Interval in Healthy Participants
NCT05818852 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALXN1007 in Healthy Male and Female Subjects
NCT01883544 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of Single- and Multiple-Ascending Doses of MH-001 in Healthy Volunteers
NCT06780254 ·Status: COMPLETED ·Phase: PHASE1
-
A Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VEL-101
NCT05238493 ·Status: COMPLETED ·Phase: PHASE1
-
Phase I Study of VLX-1005 in Healthy Subjects
NCT04783545 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate Safety and Tolerability of ACT-709478 in Healthy Subjects
NCT03165097 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of MBX 2109 in Healthy Adult Subjects
NCT05158335 ·Status: COMPLETED ·Phase: PHASE1
-
Single-Dose Escalation Study Followed by a Multiple-Dose Escalation Study of SKL24741 in Healthy Subjects
NCT04505397 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349
NCT04874324 ·Status: COMPLETED ·Phase: PHASE1
-
This Study is to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of HSK47388 in Healthy Volunteers
NCT06926218 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
A Trial of SHR-1819 in Healthy Subjects
NCT04561128 ·Status: COMPLETED ·Phase: PHASE1
-
Сlinical Study Aiming to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of ZE63-0302 in Healthy Volunteers
NCT06780124 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42847922 in Healthy Participants
NCT02230878 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, and Dose Response of VNA-318 in Healthy Males
NCT06721091 ·Status: COMPLETED ·Phase: PHASE1
-
Single and Multiple Ascending Dose Pharmacokinetic Study of TR701 in Healthy Adults
NCT00671814 ·Status: COMPLETED ·Phase: PHASE1
-
Intramuscular Dose-Escalation Study With ETI-204 in Adult Volunteers
NCT01932437 ·Status: COMPLETED ·Phase: PHASE1
-
Single and Multiple Ascending Oral Dose Study of RX-10001 in Healthy Volunteers
NCT00941018 ·Status: COMPLETED ·Phase: PHASE1