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NCT01632917 · ClinicalTrials.gov registry record · Phase 1
Open-Label Pharmacokinetic Study of Final Formulations of ATX-101
A Phase 1 study, sponsored by Kythera Biopharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01632917: Completed Phase 1 study, sponsored by Kythera Biopharmaceuticals.
NCT01632917 is a Phase 1 study that has completed, run by Kythera Biopharmaceuticals. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01632917, a Phase 1 study, has completed, sponsored by Kythera Biopharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The objectives of this trial are to evaluate the safety and tolerability of ATX-101 injections and to characterize the pharmacokinetic profile of the two ATX-101 formulations.
Primary Outcome
Spontaneously reported adverse events, laboratory test results, and treatment area evaluations including, but not limited to evaluation of edema, bruising, dysphagia, dysphonia, erythema, dyspigmentation, induration, numbness, pain, paresthesia, and pruritus.
Interventions
- DRUG ATX-101 - U.S.
- DRUG ATX-101 - EU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-06 |
| Est. Completion | 2012-07 |
| Phase | Phase 1 |
What the finished NCT01632917 record still lists
NCT01632917 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which ATX-101 - U.S. is the first listed.
NCT01632917 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01632917 about?
NCT01632917 is a clinical study titled "Open-Label Pharmacokinetic Study of Final Formulations of ATX-101". The objectives of this trial are to evaluate the safety and tolerability of ATX-101 injections and to characterize the pharmacokinetic profile of the two ATX-101 formulations.
What is the current status of trial NCT01632917?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-06. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01632917?
The interventions under investigation include: ATX-101 - U.S. (DRUG), ATX-101 - EU (DRUG).
Who is sponsoring clinical trial NCT01632917?
This trial is sponsored by Kythera Biopharmaceuticals, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01632917's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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