Clinical Trial

Testing Experimental Medication in Healthy Subjects

Study Description

Evaluation of Safety, Tolerability, Pharmacokinetics, Drug-Drug and Food Interactions of Single and Multiple Doses of S-648414 in Healthy Adults

The primary objective of Part 1 of the study is to evaluate the safety and tolerability of S-648414 after administration of a single oral dose of S-648414 in healthy adult study participants. The primary objective of Part 2 is to evaluate the safety and tolerability of S-648414 after administration of multiple oral doses of S-648414 in healthy adult study participants. The primary objective of Part 3 is to evaluate the effect of S-648414 on the PK of dolutegravir and the effect of dolutegravir on the PK of S-648414 in healthy adult study participants.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - S-648414

Tablet for oral administration

Drug - Placebo

Tablet for oral administration

Drug - Midazolam

Solution for oral administration

Drug - Dolutegravir

Tablet for oral administration

Additional Information

Official Study 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)

Clinical Trial ID

NCT04147715

ParticipAid ID

elYG6a