NCT01188525

Brief Summary

The study aims to descibe the pharmacokinetics of 10 substrates of enzymes involved in drug metabolism and their metabolites, after administration singly and simultaenously at predefined doses in 10 health volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Aug 2010

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2010

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 25, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

September 3, 2025

Status Verified

May 1, 2012

Enrollment Period

11 months

First QC Date

July 9, 2010

Last Update Submit

August 26, 2025

Conditions

Healthy Volunteers

Keywords

pharmacokineticsenzymesmetabolism prediction

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic parameters

    The aim endpoint is based on the main pharmacokinetic parameters of each subject for all substrates and all metabolites. These main parameters are the area under the curve (AUC), the maximum concentration (Cmax), the half-life (T1/2)and the ratios of AUCs of the substrate and metabolites

    one week

Secondary Outcomes (3)

  • Tolerance of the concomittant administration of the 10 drugs: 1/number of volunteers with grade 4 adverse events 2/ number of volunteers with any adverse event, (grade 1 to grade 4)

    one week

  • pharmacokinetic

    one week

  • Genotypes

    one month

Interventions

10 parents drugs adminstrationDRUG

A single and concomittant administration of 10 parent drugs will be performed: Acetaminophene, cafeine, dextrometorphan, digoxin, memantine,midazolam, omeprazole, repaglinide, rosuvastatine, tolbutamide.

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of clinical investigation

Paris, 75018, France

Location

Related Publications (1)

  • Lenuzza N, Duval X, Nicolas G, Thevenot E, Job S, Videau O, Narjoz C, Loriot MA, Beaune P, Becquemont L, Mentre F, Funck-Brentano C, Alavoine L, Arnaud P, Delaforge M, Benech H. Safety and pharmacokinetics of the CIME combination of drugs and their metabolites after a single oral dosing in healthy volunteers. Eur J Drug Metab Pharmacokinet. 2016 Apr;41(2):125-38. doi: 10.1007/s13318-014-0239-0. Epub 2014 Dec 3.

    PMID: 25465228BACKGROUND

Study Officials

  • DUVAL Xavier, doctor

    Center of clinical investigation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2010

First Posted

August 25, 2010

Study Start

August 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

September 3, 2025

Record last verified: 2012-05

Locations

FR(1)