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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: Completed Phase 1 study, sponsored by Shionogi.
NCT04147715 is a Phase 1 study that has completed, run by Shionogi. The registered enrollment target is 98 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A TEAE is any event not present before exposure to study drug or any event already present that worsens after exposure to study drug. A serious adverse event is any untoward medical occurrence that resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or other event that may have jeopardized the participant or required intervention to prevent one of the outcomes above. The i
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 |
What the finished NCT04147715 record still lists
NCT04147715 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04147715 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04147715's enrollment target sits among peer trials
98 592nd of 2000 higher than 1,404 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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