Status:
COMPLETED
A Study to Evaluate Absolute Bioavailability, Absorption, Metabolism, and Excretion of Genz-112638 in Healthy Male Participants
Lead Sponsor:
Sanofi
Conditions:
Gaucher's Disease Type I
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
Objectives: To determine pharmacokinetic (PK) variables, including absolute bioavailability (F), of Genz-99067, the free base of the L-tartaric acid salt of Genz-112638 as it exists in plasma, after ...
Detailed Description
The maximum study duration for an individual subject was approximately 65 days from the beginning of Screening through the Safety Follow-up visit.
Eligibility Criteria
Inclusion
- Having given written informed consent prior to undertaking any study-related procedure The subject has a body weight of 50 to 100 kg \[110 to 220 pounds (lb)\] with a body mass index (BMI) less than 30 kilograms per square meter (kg/m2) at Screening.
- The subject's physical examination results, vital signs, laboratory assessments, and cardiac assessments are within normal limits or, if abnormal, are not clinically significant at Screening and Day -1.
Exclusion
- Participants are excluded from the study if any of the following criteria apply:
- Prolonged QTc interval (eg, repeated demonstration of a QTc interval ≥450 msec), family history of long QT or Brugada Syndrome, and/or history of sudden death in a first-degree relative.
- The subject receives an immunization within 30 days of providing informed consent.
- The subject has a history of drug allergies (eg, significant rash, hives, etc in response to antibiotics).
- The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Key Trial Info
Start Date :
June 3 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06143904
Start Date
June 3 2009
End Date
July 5 2009
Last Update
November 22 2023
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