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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 is a Phase 1 study of Healthy Postmenopausal Women that has completed, run by Amneal Pharmaceuticals. The registered enrollment target is 18 participants. The trial reports 2 study locations across 2 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06467201
The ClinicalTrials.gov registry entry for NCT06467201 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 Amneal Pharmaceuticals, which has 8 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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