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Clinical trial

A Phase 1, Randomized, Double-Blind, Single-Ascending-Dose, and Food Effect Study to Assess the Safety, Tolerability, Ventricular Repolarization, and Pharmacokinetics of S-648414 in Healthy Adult Study Participants (Part 1); A Phase 1, Randomized, Double-Blind, Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of S-648414 and A Drug-Drug Interaction Study With the CYP3A Substrate, Midazolam, in Healthy Adult Study Participants (Part 2)

NCT04147715 is registered in ClinicalTrials.gov with Shionogi as lead sponsor.

NCT NCT04147715
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 1, Randomized, Double-Blind, Single-Ascending-Dose, and Food Effect Study to Assess the Safety, Tolerability, Ventricular Repolarization, and Pharmacokinetics of S-648414 in Healthy Adult Study Participants (Part 1); A Phase 1, Randomized, Double-Blind, Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of S-648414 and A Drug-Drug Interaction Study With the CYP3A Substrate, Midazolam, in Healthy Adult Study Participants (Part 2)
Lead sponsor
Shionogi
Phase
Phase 1
Overall status
Completed
Start date
October 9, 2019
Completion date
September 29, 2020
Enrollment
98 (actual)
Sites
2

Conditions

As the registry lists them; a condition with its own page is linked.

healthy volunteer