Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene

Phase 1

Completed

• Conditions: Disorder Due Cytochrome P450 CYP2D6 Variant; Cytochrome P450 CYP3A Enzyme Deficiency; Anovulation
• Interventions: Drug: Clomiphene; Drug: clomiphene and paroxetine; Drug: clomiphene and clarithromycin

• Registration Number: NCT01289756
• Lead Sponsor: Robert Bosch Gesellschaft für Medizinische Forschung mbH

Brief Summary

Aim of the study is the clinical validation of the metabolism and the pharmakokinetic of Clomifen in correlation to CYP2D6 and inhibition of CYP3A4.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2011-02-02
• Study First Submitted QC: 2011-02-03
• Study First Posted: 2011-02-04
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-23
• Last Update Posted: 2015-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Healthy
• Female caucasians
• Age 18 - 45 years old
• BMI 18.5 - 26 kg/m2

Exclusion Criteria

• Persons with known sensitivity of Clomifen and/or Paroxetine and/or Clarithromycin
• Pregnancy/lactation period
• Meno-/postmenopausal
• Smokers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CYP2D6 PM	clomiphene and paroxetine	clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
CYP2D6 UM	clomiphene and paroxetine	clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
CYP2D6 EM	clomiphene and paroxetine	clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
CYP2D6 IM	clomiphene and paroxetine	clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
CYP2D6 IM	clomiphene and clarithromycin	clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
CYP2D6 EM	clomiphene and clarithromycin	clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
CYP2D6 UM	clomiphene and clarithromycin	clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
CYP2D6 PM	clomiphene and clarithromycin	clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
CYP2D6 UM	Clomiphene	clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
CYP2D6 EM	Clomiphene	clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
CYP2D6 IM	Clomiphene	clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
CYP2D6 PM	Clomiphene	clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC)of clomiphene	1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after durg application	AUC of clomiphene and metabolites
Peak Plasma Concentration (Cmax)of Clomiphene	1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after drug application	Cmax of Clomiphene and metabolites

Secondary Outcome Measures

Name	Time	Method
Clearance of Clomiphene	4, 8, 12 and 24 hours after drug application	Clearance of Clomiphene and metabolites
Tmax of clomiphene	4, 8, 12, 24 hours after drug application	Tmax of clomiphene and metabolites
Pharmacogenomics	once	Pharmacogenomics
Metabolomic	4, 8, 12 and 24 hours after drug application	Metabolomic

Trial Locations

Locations (1)

Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology and University of Tuebingen; 🇩🇪 Stuttgart, BW, Germany