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NCT04147715 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Safety, Tolerability, Pharmacokinetics, Drug-Drug and Food Interactions of Single and Multiple Doses of S-648414 in Healthy Adults
A Phase 1 study, sponsored by Shionogi.
- Completed
- Registry status
- Phase 1
- Development phase
- 98
- Enrollment target
NCT04147715 is a Phase 1 study that has completed, run by Shionogi. The registered enrollment target is 98 participants.
The verdict
NCT04147715, a Phase 1 study, has completed, sponsored by Shionogi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 98 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Midazolam
- DRUG Dolutegravir
- DRUG S-648414
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2019-10-09 |
| Est. Completion | 2020-09-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04147715
The ClinicalTrials.gov registry entry for NCT04147715 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shionogi, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04147715 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04147715 about?
NCT04147715 is a clinical study titled "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...
What is the current status of trial NCT04147715?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2019-10-09. Estimated completion is 2020-09-29.
What interventions are being tested in trial NCT04147715?
The interventions under investigation include: Placebo (DRUG), Midazolam (DRUG), Dolutegravir (DRUG), S-648414 (DRUG).
Who is sponsoring clinical trial NCT04147715?
This trial is sponsored by Shionogi, which has 54 total clinical trials registered on ClinicalTrials.gov.
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