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

Primary Purpose

Anovulation, Disorder Due Cytochrome P450 CYP2D6 Variant, Cytochrome P450 CYP3A Enzyme Deficiency

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Clomiphene

clomiphene and paroxetine

clomiphene and clarithromycin

About this trial

This is an interventional basic science trial for Anovulation focused on measuring pharmacokinetic, clomiphene, CYP2D6 polymorphisms, inhibition of CYP2D6 and CYP3A4

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology and University of Tuebingen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

CYP2D6 EM

CYP2D6 IM

CYP2D6 PM

CYP2D6 UM

Arm Description

clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin

Outcomes

Primary Outcome Measures

Area under the plasma concentration versus time curve (AUC)of clomiphene

AUC of clomiphene and metabolites

Peak Plasma Concentration (Cmax)of Clomiphene

Cmax of Clomiphene and metabolites

Secondary Outcome Measures

Clearance of Clomiphene

Clearance of Clomiphene and metabolites

Metabolomic

Tmax of clomiphene

Tmax of clomiphene and metabolites

Pharmacogenomics

Full Information

NCT ID

NCT01289756

First Posted

February 2, 2011

Last Updated

February 23, 2015

Sponsor

Robert Bosch Gesellschaft für Medizinische Forschung mbH

1. Study Identification

Unique Protocol Identification Number

NCT01289756

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Robert Bosch Gesellschaft für Medizinische Forschung mbH

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anovulation, Disorder Due Cytochrome P450 CYP2D6 Variant, Cytochrome P450 CYP3A Enzyme Deficiency

Keywords

pharmacokinetic, clomiphene, CYP2D6 polymorphisms, inhibition of CYP2D6 and CYP3A4

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CYP2D6 EM

Arm Type

Experimental

Arm Description

clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin

Arm Title

CYP2D6 IM

Arm Type

Experimental

Arm Description

clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin

Arm Title

CYP2D6 PM

Arm Type

Experimental

Arm Description

clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin

Arm Title

CYP2D6 UM

Arm Type

Experimental

Arm Description

clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin

Intervention Type

Drug

Intervention Name(s)

Clomiphene

Intervention Description

clomiphene once 100 mg oral

Intervention Type

Drug

Intervention Name(s)

clomiphene and paroxetine

Intervention Description

clomiphene 100mg and paroxetine 3x40mg

Intervention Type

Drug

Intervention Name(s)

clomiphene and clarithromycin

Intervention Description

clomiphene 100mg and clarithromycin 9x500mg

Primary Outcome Measure Information:

Title

Area under the plasma concentration versus time curve (AUC)of clomiphene

Description

AUC of clomiphene and metabolites

Time Frame

1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after durg application

Title

Peak Plasma Concentration (Cmax)of Clomiphene

Description

Cmax of Clomiphene and metabolites

Time Frame

1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after drug application

Secondary Outcome Measure Information:

Title

Clearance of Clomiphene

Description

Clearance of Clomiphene and metabolites

Time Frame

4, 8, 12 and 24 hours after drug application

Title

Metabolomic

Description

Metabolomic

Time Frame

4, 8, 12 and 24 hours after drug application

Title

Tmax of clomiphene

Description

Tmax of clomiphene and metabolites

Time Frame

4, 8, 12, 24 hours after drug application

Title

Pharmacogenomics

Description

Pharmacogenomics

Time Frame

once

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthias Schwab, Prof.

Organizational Affiliation

Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology and University of Tuebingen

City

Stuttgart

State/Province

ZIP/Postal Code

70376

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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