drugset
drugset / Trial / NCT04147715

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

NCT04147715 ↗

Phase 1 Completed 98 enrolled Shionogi
RandomizedSequentialDouble-blindTreatment

Summary

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 objectives of Part 3 are evaluate the safety and tolerability of S-648414 after administration of multiple oral doses of S-648414 in healthy adult study participants, and to evaluate the effect of S-648414 on the pharmacokinetics (PK) of dolutegravir and the effect of dolutegravir on the PK of S-648414 in healthy adult study participants.

Timeline

Start
2019-10-09
Primary completion
2020-09-22
Completion
2020-09-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Dolutegravir Other / unclassified 50 mg Oral
Subject Midazolam Small molecule 5 mg Oral
Subject S-648414 Unknown 10 mg Oral
Subject S-648414 Unknown 30 mg Oral
Subject S-648414 Unknown 50 mg Oral
Subject S-648414 Unknown 100 mg Oral
Subject S-648414 Unknown 200 mg Oral
Subject S-648414 Unknown 250 mg Oral
Subject S-648414 Unknown 500 mg Oral
Subject S-648414 Unknown 1000 mg Oral

Indications

No indication recorded.