CompletedPhase 1

A Study to Evaluate Absolute Bioavailability, Absorption, Metabolism, and Excretion of Genz-112638 in Healthy Male Participants

10 participantsStarted 2009-06-03

Plain-language 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 a single intravenous (IV) dose and after a single oral dose of Genz-112638 (unlabeled). To determine the PK, total recovery, routes and rates of excretion, and the metabolic profile of Genz-99067 after 5 days of BID oral dosing with unlabeled Genz-112638 followed by a single dose of \[14C\]-Genz-112638.

Who can participate

Age range18 Years – 45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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 Criteria: 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.

What they're measuring

Assessment of pharmacokinetic (PK) parameter: Cmax

Timeframe: Multiple timepoints up to Day 26

Assessment of pharmacokinetic (PK) parameter: Tmax

Timeframe: Multiple timepoints up to Day 26

Assessment of pharmacokinetic (PK) parameter: AUC0-∞

Timeframe: Multiple timepoints up to Day 26

Assessment of pharmacokinetic (PK) parameter: AUC0 -τ

Timeframe: Multiple timepoints up to Day 26

Assessment of pharmacokinetic (PK) parameter: AUC0-∞/D

Timeframe: Multiple timepoints up to Day 26

Assessment of pharmacokinetic (PK) parameter: AUC0-τ/D

Timeframe: Multiple timepoints up to Day 26

Assessment of pharmacokinetic (PK) parameter: F

Timeframe: Multiple timepoints up to Day 26

Assessment of pharmacokinetic (PK) parameter: CL/F

Timeframe: Multiple timepoints up to Day 26

Trial details

NCT IDNCT06143904

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-07-05

View on ClinicalTrials.gov More Gaucher's Disease Type I trials

Plain-language summary

Who can participate

Age range18 Years – 45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Assessment of pharmacokinetic (PK) parameter: Cmax

Timeframe: Multiple timepoints up to Day 26

Assessment of pharmacokinetic (PK) parameter: Tmax

Timeframe: Multiple timepoints up to Day 26

Assessment of pharmacokinetic (PK) parameter: AUC0-∞

Timeframe: Multiple timepoints up to Day 26

Assessment of pharmacokinetic (PK) parameter: AUC0 -τ

Timeframe: Multiple timepoints up to Day 26

Assessment of pharmacokinetic (PK) parameter: AUC0-∞/D

Timeframe: Multiple timepoints up to Day 26

Assessment of pharmacokinetic (PK) parameter: AUC0-τ/D

Timeframe: Multiple timepoints up to Day 26

Assessment of pharmacokinetic (PK) parameter: F

Timeframe: Multiple timepoints up to Day 26

Assessment of pharmacokinetic (PK) parameter: CL/F

Timeframe: Multiple timepoints up to Day 26