A Phase 1, Open-label Study Evaluating the Pharmacokinetics and Drug-drug Interaction of VX-993 in Healthy Adults
NCT06392659 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2024-08-01
Summary
The purpose of this study is to evaluate the pharmacokinetics (PK), drug-drug interaction, and safety and tolerability of VX-993 in healthy participants.
Conditions
Interventions
- DRUG
-
VX-993
Suspension for Oral Administration.
- DRUG
-
Gemfibrozil
Tablets for Oral Administration.
- DRUG
-
Itraconazole
Capsules for Oral Administration.
- DRUG
-
Midazolam
Solution for Oral Administration.
Sponsors & Collaborators
-
Vertex Pharmaceuticals Incorporated
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-05-02
- Primary Completion
- 2024-07-02
- Completion
- 2024-07-02
- FDA Drug
- Yes
Countries
- United Kingdom
Study Locations
More Related Trials
-
Phase 1 PK Interaction Study Between VX-509 and Prednisone or Methylprednisolone in Healthy Male Subjects
NCT01886209 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I, Open Interaction Study Between GLPG1837 and Midazolam in Healthy Male Subjects
NCT02562950 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Effect of Multiple Doses of AZD5718 on Pharmacokinetics of Oral Midazolam in Healthy Subjects
NCT04492709 ·Status: COMPLETED ·Phase: PHASE1
-
A Drug-Drug Interaction Study To Investigate The Ginkgolides Meglumine Injection To Alter The Pharmacokinetics Of Midazolam
NCT02233972 ·Status: COMPLETED ·Phase: PHASE4
-
Safety, Tolerability and Pharmacokinetics of ERX-963 in Adults With Myotonic Dystrophy Type 1
NCT03959189 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Pharmacokinetics of Midazolam After Repeated Doses of Camizestrant (AZD9833) and to Investigate the Pharmacokinetics of Camizestrant When Administered Alone and in Combination With Carbamazepine in Healthy Post-Menopausal Female Participants
NCT06547164 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess the Effect of Co-Administration of AZD9833 on the Pharmacokinetics of Midazolam, of Omeprazole, of Celecoxib and of Dabigatran Etexilate in Healthy Postmenopausal Female Volunteers
NCT05438303 ·Status: COMPLETED ·Phase: PHASE1
-
A Drug-Drug Interaction Study Between ATI-2173 and Midazolam or Clarithromycin in Healthy Subjects
NCT05137600 ·Status: COMPLETED ·Phase: PHASE1
-
A Drug-Drug Interaction Study to Evaluate the Effect of Vapendavir on the Pharmacokinetics of Midazolam in Healthy Male and Female Volunteers
NCT02204501 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Drug-drug Interactions (DDIs) Between SKLB1028 and Midazolam in Healthy Subjects
NCT05070195 ·Status: COMPLETED ·Phase: PHASE1
-
CKD-506 Drug-Drug Interaction Study in Healthy Male Subjects
NCT05238948 ·Status: COMPLETED ·Phase: PHASE1
-
A Drug-drug Interaction Study With TS-172 in Healthy Adult Male Subjects
NCT06837142 ·Status: COMPLETED ·Phase: PHASE1
-
Drug Interaction Study of ZYN002 Transdermal Gel and Probe Substrates
NCT06930872 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Effect of Itraconazole, Phenytoin and Gemfibrozil on the Drug Levels of BMS-986166 in Healthy Participants
NCT04956627 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Tepotinib on PK of CYP3A Substrate Midazolam
NCT03628339 ·Status: COMPLETED ·Phase: PHASE1
-
A Drug-Drug Interaction Study Between GDC-0853 and Midazolam, Itraconazole, Rosuvastatin, and Simvastatin
NCT03174041 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Determine the Effect of KP-001 on Metformin and Midazolam Pharmacokinetics and the Effect of Clarithromycin on KP-001 Pharmacokinetics in Healthy Adult Participants
NCT06227832 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on BMS-986278 in Healthy Participants
NCT05932303 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Interaction of Other Drugs With TAK-279 in Healthy Adults
NCT06290050 ·Status: COMPLETED ·Phase: PHASE1
-
AZD1981 Midazolam CYP4503A Induction Study
NCT00859352 ·Status: COMPLETED ·Phase: PHASE1
-
A Drug-Drug Interaction Study to Assess the Pharmacokinetics of DC-806 When Orally Administered Alone, When Coadministered With Itraconazole, and When Coadministered With Carbamazepine in Healthy Adult Participants
NCT05994807 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of PBI-4050 on the Pharmacokinetics of Midazolam in Heathy Adult Subjects
NCT03637049 ·Status: COMPLETED ·Phase: PHASE1
-
Drug-Drug Interaction Study to Estimate the Effect of PF-07321332/Ritonavir and Ritonavir on Midazolam in Healthy Participants
NCT05032950 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of BI 1181181 on Midazolam, Warfarin, Omeprazole and Digoxin
NCT02345304 ·Status: WITHDRAWN ·Phase: PHASE1
-
Thorough QT Assessment of Cedazuridine in Healthy Subjects
NCT04953923 ·Status: COMPLETED ·Phase: PHASE1