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NCT02374047 · ClinicalTrials.gov registry record · Phase 1
A 2-Part, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CAT-2054 in Healthy Subjects
A Phase 1 study, sponsored by Catabasis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 118
- Enrollment target
NCT02374047 is a Phase 1 study that has completed, run by Catabasis Pharmaceuticals. The registered enrollment target is 118 participants.
The verdict
NCT02374047, a Phase 1 study, has completed, sponsored by Catabasis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 118 participants
- Enrollment target
Study Summary
This is a 2-part, Phase 1, placebo-controlled, double-blind, randomized, single and multiple ascending dose study. CAT-2054 will be administered either as an uncoated capsule (CAT-2054) or a coated capsule (CAT-2054-C). In Part A, CAT-2054 or placebo is administered as a single dose in a fasting state at 4 dose levels; at 3 dose levels, subjects will return for a second dose of the study drug after a high-fat meal. Additionally, at 1 dose level, CAT-2054-C or placebo will be administered as a single dose in a fasting state, and subjects will return for a second dose of the study drug after a high-fat meal. In Part B, CAT-2054 will be administered as multiple ascending doses at 4 dose levels for 14 consecutive days. In selected cohorts, CAT-2054, CAT-2054-C or CAT-2054 with atorvastatin will be dosed to assess safety in anticipation of future clinical trials.
Interventions
- DRUG Placebo
- DRUG Atorvastatin
- DRUG CAT-2054
- DRUG CAT-2054-C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2015-01 |
| Est. Completion | 2015-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02374047
The ClinicalTrials.gov registry entry for NCT02374047 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Catabasis Pharmaceuticals, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02374047 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02374047 about?
NCT02374047 is a clinical study titled "A 2-Part, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CAT-2054 in Healthy Subjects". This is a 2-part, Phase 1, placebo-controlled, double-blind, randomized, single and multiple ascending dose study. CAT-2054 will be administered either as an uncoated capsule (CAT-2054) or a coated capsule (CAT-2054-C). In Part A, CAT-2054 or placebo is administered as a single dose in a fasting sta...
What is the current status of trial NCT02374047?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 118 participants. The study started on 2015-01. Estimated completion is 2015-07.
What interventions are being tested in trial NCT02374047?
The interventions under investigation include: Placebo (DRUG), Atorvastatin (DRUG), CAT-2054 (DRUG), CAT-2054-C (DRUG).
Who is sponsoring clinical trial NCT02374047?
This trial is sponsored by Catabasis Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov.
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