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NCT01519531 · ClinicalTrials.gov registry record · Phase 1
Ascending Multiple-Dose Study to Evaluate VIA-3196 in Healthy Subjects
A Phase 1 study of Drug Safety, sponsored by Madrigal Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT01519531: Completed Phase 1 study of Drug Safety, sponsored by Madrigal Pharmaceuticals.
NCT01519531 is a Phase 1 study of Drug Safety that has completed, run by Madrigal Pharmaceuticals. The registered enrollment target is 48 participants, below the 92-participant average among 4 other Drug Safety trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01519531, a Phase 1 study of Drug Safety, has completed, sponsored by Madrigal Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-center, randomized, double-blind, placebo-controlled, ascending multiple-dose study of VIA-3196 to evaluate the Safety, Pharmacokinetics and Pharmacodynamics of VIA-3196 in Healthy Subjects. Study dosing is organized into cohorts corresponding to escalating doses of VIA-3196 or matching placebo. Subjects will be dosed daily for 14 days.
Primary Outcome
Evaluation will start from predose (Day -1) until the follow-up visit (Day 21)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG VIA-3196
Study Locations (1)
North Dakota
- PRACS Institute (formerly Cetero Research) - Fargo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2012-01 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
What the finished NCT01519531 record still lists
NCT01519531 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 92-participant average among 4 other Drug Safety trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Drug Safety appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01519531 reports a single indexed study location in North Dakota.
Frequently Asked Questions
What is clinical trial NCT01519531 about?
NCT01519531 is a clinical study titled "Ascending Multiple-Dose Study to Evaluate VIA-3196 in Healthy Subjects". This is a single-center, randomized, double-blind, placebo-controlled, ascending multiple-dose study of VIA-3196 to evaluate the Safety, Pharmacokinetics and Pharmacodynamics of VIA-3196 in Healthy Subjects. Study dosing is organized into cohorts corresponding to escalating doses of VIA-3196 or matc...
What is the current status of trial NCT01519531?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2012-01. Estimated completion is 2012-11.
What conditions does trial NCT01519531 study?
This clinical trial studies the following conditions: Drug Safety.
What interventions are being tested in trial NCT01519531?
The interventions under investigation include: Placebo (DRUG), VIA-3196 (DRUG).
Who is sponsoring clinical trial NCT01519531?
This trial is sponsored by Madrigal Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01519531 being conducted?
This trial has 1 study location across North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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