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NCT04973657 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Pharmacodynamics of VK0214 in Male Subjects With AMN
A Phase 1 study of Adrenomyeloneuropathy Form (AMN) of X-linked Adrenoleukodystrophy (X-ALD), sponsored by Viking Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 9
- Study locations
NCT04973657 is a Phase 1 study of Adrenomyeloneuropathy Form (AMN) of X-linked Adrenoleukodystrophy (X-ALD) that has completed, run by Viking Therapeutics. The registered enrollment target is 24 participants. The trial reports 9 study locations across 5 states.
The verdict
NCT04973657, a Phase 1 study of Adrenomyeloneuropathy Form (AMN) of X-linked Adrenoleukodystrophy (X-ALD), has completed, sponsored by Viking Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 9
- Study locations
Study Summary
Subjects will be administered multiple doses of VK0214 in a cohort dose escalation process. A total of up to 36 subjects will be enrolled in the study, into one of three dose cohorts. For each cohort, up to 12 subjects will be randomized to receive VK0214 or placebo in a 3:1 ratio so that there will be a total of up to 9 subjects for each of the active doses and up to 3 subjects dosed with placebo in each cohort.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG VK0214
Study Locations (9)
Other
- Viking Clinical Site 214 - Bordeaux
- Viking Clinical Site 215 - Montpellier
- Viking Clinical Site 209 - Leipzig
- Viking Clinical Site 210 - Milan
- Viking Clinical Site 212 - London
California
- Viking Clinical Site 203 - Palo Alto
Florida
- Viking Clinical Site 207 - Gainesville
Maryland
- Viking Clinical Site 201 - Baltimore
Washington
- Viking Clinical Site 205 - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-06-22 |
| Est. Completion | 2024-11-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04973657
The ClinicalTrials.gov registry entry for NCT04973657 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Viking Therapeutics, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Adrenomyeloneuropathy Form (AMN) of X-linked Adrenoleukodystrophy (X-ALD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04973657 reports 9 study locations spanning 5 distinct geographic areas - top geographies include Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT04973657 about?
NCT04973657 is a clinical study titled "A Study to Assess the Pharmacodynamics of VK0214 in Male Subjects With AMN". Subjects will be administered multiple doses of VK0214 in a cohort dose escalation process. A total of up to 36 subjects will be enrolled in the study, into one of three dose cohorts. For each cohort, up to 12 subjects will be randomized to receive VK0214 or placebo in a 3:1 ratio so that there will...
What is the current status of trial NCT04973657?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2021-06-22. Estimated completion is 2024-11-08.
What conditions does trial NCT04973657 study?
This clinical trial studies the following conditions: Adrenomyeloneuropathy Form (AMN) of X-linked Adrenoleukodystrophy (X-ALD).
What interventions are being tested in trial NCT04973657?
The interventions under investigation include: Placebo (OTHER), VK0214 (DRUG).
Who is sponsoring clinical trial NCT04973657?
This trial is sponsored by Viking Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04973657 being conducted?
This trial has 9 study locations across California, Florida, Maryland, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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