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NCT00060515 Clinical Trial

RG2133 (2',3',5'-Tri-O-Acetyluridine) in Mitochondrial Disease

Mitochondrial Diseases Clinical Trial

Official title:
An Open-Label Dose-Escalation Phase I Study to Asses the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RG2133 (2',3',5'-Tri-O-Acetyluridine) in the Treatment of Inherited Mitochondrial Diseases

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00060515
Other study ID # RG2133-01
Secondary ID
Status Terminated
Phase Phase 1
First received May 7, 2003
Last updated August 4, 2005

Study information
Verified date August 2005
Source Repligen Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The objective of the study is to determine the safety and tolerability of RG2133 in patients with Mitochondrial Disease.

Recruitment information / eligibility
Status Terminated
Enrollment 12
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 3 Years and older
Eligibility Mitochondrial Disease

Study Design

Allocation: Non-Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• RG2133 (2',3',5'-tri-O-acetyluridine)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Repligen Corporation
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