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 range

18 Years – 45 Years

Sex

MALE

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years – 45 Years

Sex

MALE

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