Safety and Pharmacokinetic Study of C13-URA in Healthy Volunteers
A Phase I, Double-Blind, Placebo-Controlled, Randomized, 3-Period, Safety and Pharmacokinetic Study of 13C-uracil in a Semi-solid Meal at Single Oral Doses of 50, 100, and 200 mg in Healthy Volunteers
1 other identifier
interventional
8
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety and establish the pharmacokinetic (PK) profile of C13-URA in healthy volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 18, 2010
CompletedFirst Posted
Study publicly available on registry
February 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJuly 19, 2010
May 1, 2010
3 months
February 18, 2010
July 16, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
PK parameters
Pharmacokinetic endpoints will include apparent clearance (CL/F), AUCt, AUC∞, Cmax, tmax, and t1/2,Z for 13C-uracil and its metabolites. The PK linearity and correlation between plasma concentration and urine excretion will be evaluated. Expired 13CO2 concentrations (Δ13C) will be converted to 13CO2-excretion(% dose/hr) to assess breath PK parameters (AUCt, AUC∞, Cmax, tmax, λZ, and t1/2,Z).
6 hours
Study Arms (2)
C13-URA
EXPERIMENTALadministered C13-URA 50, 100, 200mg in same subjects
Placebo
PLACEBO COMPARATOR2 same subjects
Interventions
Eligibility Criteria
You may qualify if:
- Body mass index \[range is 18.5 to 29.9 kg/m2\]
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs
You may not qualify if:
- Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the investigator)
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (except that appendectomy, hernia repair, and/or cholecystectomy will be allowed)
- History or presence of an abnormal ECG, which, in the investigator's opinion, is clinically significant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Covance Clinical Pharmacology, Inc.
Madison, Wisconsin, 53704, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen D Flach, MD, PhD, CPI
Covance Clinical Pharmacology, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 18, 2010
First Posted
February 24, 2010
Study Start
February 1, 2010
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
July 19, 2010
Record last verified: 2010-05