An Open-Label Study to Evaluate the Absolute Bioavailability of Genz-112638 and the Absorption, Metabolism, and Excretion of [14C]-Genz-112638 in Male Subjects
Sponsor study identifier
Secondary identifiers
REGISTRY · ICTRP
interventional
10
0 countries
N/A
Study Start
June 3, 2009
Actual (reported)Primary Completion
July 5, 2009
Actual (reported)Study Completion
July 5, 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 5, 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 3, 2009
Actual (reported)July 5, 2009
Actual (reported)July 5, 2009
Actual (reported)November 16, 2023
Actual (reported)November 22, 2023
Actual (reported)Assessment of pharmacokinetic (PK) parameter: Cmax
Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints
Multiple timepoints up to Day 26
Assessment of pharmacokinetic (PK) parameter: Tmax
Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints
Multiple timepoints up to Day 26
Assessment of pharmacokinetic (PK) parameter: AUC0-∞
Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints
Multiple timepoints up to Day 26
Assessment of pharmacokinetic (PK) parameter: AUC0 -τ
Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints
Multiple timepoints up to Day 26
Assessment of pharmacokinetic (PK) parameter: AUC0-∞/D
Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints
Multiple timepoints up to Day 26
Assessment of pharmacokinetic (PK) parameter: AUC0-τ/D
Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints
Multiple timepoints up to Day 26
Assessment of pharmacokinetic (PK) parameter: F
Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints
Multiple timepoints up to Day 26
Assessment of pharmacokinetic (PK) parameter: CL/F
Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints
Multiple timepoints up to Day 26
Assessment of pharmacokinetic (PK) parameter: t½
Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints
Multiple timepoints up to Day 26
Pharmacokinetic (PK) parameter: Absolute bioavailability (F) of single-dose oral versus single-dose IV administration
Multiple timepoints up to Day 26
Assessment of pharmacokinetic (PK) parameter: Total radioactivity excreted in urine and feces
Total radioactivity excreted in urine and feces will be converted to percentage of radioactive dose.
Multiple timepoints up to Day 26
Assessment of pharmacokinetic (PK) parameter: Total radioactivity in whole blood and plasma
Total radioactivity in whole blood and plasma will be converted to ngEq/g Genz-99067 concentration for whole blood and ngEq/mL for plasma, based on the dose specific activity.
Multiple timepoints up to Day 26
Assessment of pharmacokinetic (PK) parameter: % relative abundance of each component in samples of plasma or excreta
It will be estimated as \[(radioactivity for the HPLC peak)/(total radioactivity injected per HPLC run) x 100\].
Multiple timepoints up to Day 26
Assessment of pharmacokinetic (PK) parameter: The percentage of the administered dose attributed to each component in samples of urine or feces
It will be estimated as \[(% relative abundance)/100 x (percentage of radioactive dose in the sample)\].
Multiple timepoints up to Day 26
Assessment of pharmacokinetic (PK) parameter: The radioactivity of [14C]-Genz-99067 and each major metabolite in plasma, as identified by radio-profiling
It will be converted to equivalent concentrations as \[(% relative abundance)/100 x (equivalent concentration of total radioactivity in the sample)\].
Multiple timepoints up to Day 26
Noncompartmental PK parameters: AUC0-t
Multiple timepoints up to Day 26
Noncompartmental PK parameters: AUC0-∞
Multiple timepoints up to Day 26
Noncompartmental PK parameters: Cmax
Multiple timepoints up to Day 26
Noncompartmental PK parameters: Tmax
Multiple timepoints up to Day 26
Noncompartmental PK parameters: t½
Multiple timepoints up to Day 26
Noncompartmental PK parameters: Vz/F
Multiple timepoints up to Day 26
Noncompartmental PK parameters: CL/F
Multiple timepoints up to Day 26
Noncompartmental PK parameters for urine and feces: Cum Ae
Multiple timepoints up to Day 26
Noncompartmental PK parameters for urine and feces: % dose
Multiple timepoints up to Day 26
Renal clearance (CLR) for total plasma radioactivity and Genz-99067
Multiple timepoints up to Day 26
PK parameters [AUC0-τ, AUC0-∞, Cmax, Tmax, t½] and metabolite ratio for metabolite(s) of Genz-99067
Multiple timepoints up to Day 26
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse event (SAEs), and adverse event of special interest (AESI)
Up to Day 33
Single-dose Intravenous (IV) Genz-112638 Day 1 followed by single dose GenZ-112638 oral capsules Day 8
Single-dose Intravenous (IV) Genz-112638 Day 1; single dose GenZ-112638 oral capsules Day 8; oral capsule Genz-112638 Days 9-14; single dose \[14C\]-Genz-112638 oral solution Day 15
Pharmaceutical form:Solution-Route of administration:IV
Pharmaceutical form:Capsule-Route of administration:Oral
10 participants (actual enrollment reported by the registry).
First Submitted
November 16, 2023
First Posted
November 22, 2023
Study Start
June 3, 2009
Actual (reported)Pharmaceutical form:Solution-Route of administration:Oral
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 5, 2009
Actual (reported)Study Completion
July 5, 2009
Actual (reported)Last Updated
November 22, 2023
Record last verified: 2023-11
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: