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NCT05797701 · ClinicalTrials.gov registry record · Phase 1
A Study in Healthy Adult Male & Female Participants to Assess the Amount of the Study Medicine (SAR443820) Absorbed by the Body, When Given Orally in Fasted Condition as a Tablet Versus as a Capsule (Part 1) and When Given Orally as a Tablet in Fasted Condition Versus as a Tablet After Food (Part 2)
A Phase 1 study of Amyotrophic Lateral Sclerosis (Healthy Volunteers), sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT05797701 is a Phase 1 study of Amyotrophic Lateral Sclerosis (Healthy Volunteers) that has completed, run by Sanofi. The registered enrollment target is 18 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05797701, a Phase 1 study of Amyotrophic Lateral Sclerosis (Healthy Volunteers), has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
Part 1: This is an open label, balanced randomized, single dose, 2-sequence, 2-period (period 1 and period 2), 2-treatment crossover (between Treatment A and Treatment B for Part 1), study part to determine the relative bioavailability of SAR443820 in tablet formulation versus capsule formulation under fasted conditions. Two treatments are as follows: * Treatment A: SAR443820 - tablet formulation in fasted condition * Treatment B: SAR443820 - capsule formulation in fasted condition Each administration will be a single dose of SAR443820 separated by a wash out of at least 5 days. Part 2: This is an open-label, balanced randomized, single dose, 2-sequence, 2-period (period 1 and period 2), 2-treatment crossover (between Treatment C and Treatment D for Part 2) study part to perform a preliminary assessment of the effect of a high-fat meal on pharmacokinetic parameters of single dose of SAR443820 in tablet formulation. Two treatments are as follows: * Treatment C: SAR443820 - tablet formulation in fasted condition * Treatment D: SAR443820 - tablet formulation in fed condition Each administration will be a single dose of SAR443820 separated by a wash out of at least 5 days. Participants are not allowed to participate in more than one part of the study. In both Parts 1 and 2, the assessment of pharmacokinetic, safety and tolerability are performed at each treatment period at baseline (prior single dosing) up to 48-hour postdosing in healthy adult male and female participants.
Conditions Studied
Interventions
- DRUG SAR443820
Study Locations (1)
Minnesota
- Prism Research-Site Number:8400001 - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2021-07-28 |
| Est. Completion | 2021-09-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05797701
The ClinicalTrials.gov registry entry for NCT05797701 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Amyotrophic Lateral Sclerosis (Healthy Volunteers) appearing as the primary indexed condition, and to 1 intervention - of which SAR443820 is the first listed.
NCT05797701 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT05797701 about?
NCT05797701 is a clinical study titled "A Study in Healthy Adult Male & Female Participants to Assess the Amount of the Study Medicine (SAR443820) Absorbed by the Body, When Given Orally in Fasted Condition as a Tablet Versus as a Capsule (Part 1) and When Given Orally as a Tablet in Fasted Condition Versus as a Tablet After Food (Part 2)". Part 1: This is an open label, balanced randomized, single dose, 2-sequence, 2-period (period 1 and period 2), 2-treatment crossover (between Treatment A and Treatment B for Part 1), study part to determine the relative bioavailability of SAR443820 in tablet formulation versus capsule formulation u...
What is the current status of trial NCT05797701?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2021-07-28. Estimated completion is 2021-09-06.
What conditions does trial NCT05797701 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis (Healthy Volunteers).
What interventions are being tested in trial NCT05797701?
The interventions under investigation include: SAR443820 (DRUG).
Who is sponsoring clinical trial NCT05797701?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05797701 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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