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NCT01674036 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Pharmacokinetics of Genz-682452 in Healthy Men
A Phase 1 study of Healthy Volunteer, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
- 1
- Study location
NCT01674036: Completed Phase 1 study of Healthy Volunteer, sponsored by Genzyme, a Sanofi Company.
NCT01674036 is a Phase 1 study of Healthy Volunteer that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 63 participants, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01674036, a Phase 1 study of Healthy Volunteer, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
- 1
- Study location
Study Summary
The objectives of this study are to assess the tolerability, safety and pharmacokinetic parameters of Genz-682452 in healthy adult males, in two parts. Part 1 (GZFD00111TDU12766): double-blind, randomized, placebo-controlled, sequential ascending single dose study; Part 2 (GZFD00211FED12767): open-label, randomized, 2-sequence, 2-period, 2-treatment crossover study with a minimum wash-out period; to obtain preliminary information on the pharmacokinetics, tolerability and safety of Genz-682452 after single oral doses in fed and fasted conditions. Subjects are not allowed to participate in more than 1 part of the study.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Genz-682452
Study Locations (1)
Texas
- - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2012-08 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
What the finished NCT01674036 record still lists
NCT01674036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01674036 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01674036 about?
NCT01674036 is a clinical study titled "Safety, Tolerability and Pharmacokinetics of Genz-682452 in Healthy Men". The objectives of this study are to assess the tolerability, safety and pharmacokinetic parameters of Genz-682452 in healthy adult males, in two parts. Part 1 (GZFD00111TDU12766): double-blind, randomized, placebo-controlled, sequential ascending single dose study; Part 2 (GZFD00211FED12767): open...
What is the current status of trial NCT01674036?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2012-08. Estimated completion is 2013-01.
What conditions does trial NCT01674036 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT01674036?
The interventions under investigation include: Placebo (DRUG), Genz-682452 (DRUG).
Who is sponsoring clinical trial NCT01674036?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01674036 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01674036's enrollment target sits among peer trials
63 54th of 112 higher than 59 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer 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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