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NCT06467201 · ClinicalTrials.gov registry record · Phase 1
SAD Study to Evaluate Safety, Tolerability, and Pharmacokinetic Profile of AMN1126 in Healthy Post-Menopausal Females
A Phase 1 study of Healthy Postmenopausal Women, sponsored by Amneal Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 2
- Study locations
NCT06467201: Completed Phase 1 study of Healthy Postmenopausal Women, sponsored by Amneal Pharmaceuticals.
NCT06467201 is a Phase 1 study of Healthy Postmenopausal Women that has completed, run by Amneal Pharmaceuticals. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06467201, a Phase 1 study of Healthy Postmenopausal Women, has completed, sponsored by Amneal Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is an Open-label, Sequential dosing, Single Ascending Dose (SAD) Study to Determine the Safety, Tolerability, and Pharmacokinetic (PK) Profile of KSHN001126 in Healthy Human Post-Menopausal Female Volunteers. The primary objective of the study is to evaluate the safety and tolerability of increasing single doses of KSHN001126 while the secondary objective is to evaluate the plasma PK profile of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126.
Primary Outcome
Adverse events reported after dosing will be evaluated
Conditions Studied
Interventions
- DRUG KSHN001126 150mg
- DRUG KSHN001126 300mg
- DRUG KSHN001126 600mg
Study Locations (2)
Florida
- Advanced Pharma CR - Miami
Gujarat
- Health1 Superspeciality Hospital - Ahmedabad
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2024-06-03 |
| Est. Completion | 2025-03-12 |
| Phase | Phase 1 |
What the finished NCT06467201 record still lists
NCT06467201 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Healthy Postmenopausal Women appearing as the primary indexed condition, and to 3 interventions - of which KSHN001126 150mg is the first listed.
NCT06467201 reports a single indexed study location in Florida, Gujarat.
Frequently Asked Questions
What is clinical trial NCT06467201 about?
NCT06467201 is a clinical study titled "SAD Study to Evaluate Safety, Tolerability, and Pharmacokinetic Profile of AMN1126 in Healthy Post-Menopausal Females". This is an Open-label, Sequential dosing, Single Ascending Dose (SAD) Study to Determine the Safety, Tolerability, and Pharmacokinetic (PK) Profile of KSHN001126 in Healthy Human Post-Menopausal Female Volunteers. The primary objective of the study is to evaluate the safety and tolerability of incre...
What is the current status of trial NCT06467201?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2024-06-03. Estimated completion is 2025-03-12.
What conditions does trial NCT06467201 study?
This clinical trial studies the following conditions: Healthy Postmenopausal Women.
What interventions are being tested in trial NCT06467201?
The interventions under investigation include: KSHN001126 150mg (DRUG), KSHN001126 300mg (DRUG), KSHN001126 600mg (DRUG).
Who is sponsoring clinical trial NCT06467201?
This trial is sponsored by Amneal Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06467201 being conducted?
This trial has 2 study locations across Florida, Gujarat. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06467201's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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.
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