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NCT03387657 · ClinicalTrials.gov registry record · Phase 1
A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT03387657: Completed Phase 1 study, sponsored by Sanofi.
NCT03387657 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03387657, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
Primary Objective: To assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state pharmacokinetics (PK) of sotagliflozin. Secondary Objectives: * To assess the safety and tolerability of multiple-dose sotagliflozin with and without co-administration of multiple-dose HCTZ * To assess the effects of multiple-dose sotagliflozin on the steady-state PK of HCTZ * To assess the effects of multiple-dose HCTZ on the steady-state PK of sotagliflozin-3-O-glucuronide
Primary Outcome
Sotagliflozin without HCTZ: AUC to the end of the dosing period (AUCtau)
Interventions
- DRUG Hydrochlorothiazide
- DRUG Sotagliflozin (SAR439954)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-01-03 |
| Est. Completion | 2018-03-02 |
| Phase | Phase 1 |
What the finished NCT03387657 record still lists
NCT03387657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Hydrochlorothiazide is the first listed.
NCT03387657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03387657 about?
NCT03387657 is a clinical study titled "A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide". Primary Objective: To assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state pharmacokinetics (PK) of sotagliflozin. Secondary Objectives: * To assess the safety and tolerability of multiple-dose sotagliflozin with and without co-administration of multiple-dose HCTZ * ...
What is the current status of trial NCT03387657?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2018-01-03. Estimated completion is 2018-03-02.
What interventions are being tested in trial NCT03387657?
The interventions under investigation include: Hydrochlorothiazide (DRUG), Sotagliflozin (SAR439954) (DRUG).
Who is sponsoring clinical trial NCT03387657?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03387657's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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