A Study in Healthy Female Participants Investigating the Effect of TMC435 on the Pharmacokinetics of the Synthetic Hormones of the Oral Contraceptive Ovysmen

NCT01486004 | Completed Phase 1

• 3 other identifiers: CR100683TMC435-TiDP16-C1242011-003022-26
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 (administered once a day) on the steady-state pharmacokinetics of ethinylestradiol and norethindrone (administered once a day) and on the levels of progesterone, luteinizing hormone and follicle-stimulating hormone, in healthy female participants. Ethinlyestradiol and norethindrone are synthetic hormones, which constitute the oral contraceptive Ovysmen. Also the short-term safety and tolerability of the co-administration of TMC435 and Ovysmen will be studied. Steady-state is a term that means that the drug has been given long enough so that the plasma concentrations will remain the same with each subsequent dose. TMC435 is being investigated for the treatment of chronic hepatitis C virus (HCV) infection. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. A contraceptive is a method that prevents pregnancy.

Conditions

Hepatitis C Virus

Keywords

Hepatitis C Virus; TMC435; TMC435-TiDP16-C124; TMC435-C124; HCV; Hepatitis C; Hep C; Healthy participants

Outcome Measures

Primary Outcomes (2)

• Change in the steady-state plasma PK of ethinylestradiol following co-administration with TMC435

  PK characteristics of ethinylestradiol and norethindrone are determined based on their respective plasma levels at one time point (Day19, 20 and 22) and at 10 time points (Day22). Standard PK parameters such as C0h, Cmin, Cmax, Tmax, AUC24h etc. will be determined.

  Measured on Day19 till and including Day22 of 2nd OC cycle. Reference is Day19 till and including Day22 of 1st OC cycle.

• Change in the steady-state plasma PK of norethindrone following co-administration with TMC435

  PK characteristics of ethinylestradiol and norethindrone are determined based on their respective plasma levels at one time point (Day19, 20 and 22) and at 10 time points (Day22). Standard PK parameters such as C0h, Cmin, Cmax, Tmax, AUC24h etc. will be determined.

  Measured on Day19 till and including Day22 of 2nd OC cycle. Reference is Day19 till and including Day22 of 1st OC cycle.

Secondary Outcomes (4)

• Change in the plasma levels of progesterone following co-administration of Ovysmen and TMC435.

  Measured on Day1, 19, 20 and 21 of 2nd OC cycle. Reference is Day1, 19, 20 and 21 of 1st OC cycle.

• Number of participants (%) with adverse events as a measure of safety and tolerability when combining TMC435 (150 mg, q.d.) with Ovysmen (35 µg ethinylestradiol + 1 mg norethindrone, q.d.)

  Day of Screening + 21 days between screening and Day1 of first OC cycle + 28 days of first OC cycle + 28 days of second OC cycle

• Change in the plasma levels of luteinizing hormone following co-administration of Ovysmen and TMC435.

  Measured on Day1, 19, 20 and 21 of 2nd OC cycle. Reference is Day1, 19, 20 and 21 of 1st OC cycle.

• Change in the plasma levels of follicle-stimulating hormone following co-administration of Ovysmen and TMC435.

  Measured on Day1, 19, 20 and 21 of 2nd OC cycle. Reference is Day1, 19, 20 and 21 of 1st OC cycle.

Study Arms (1)

001

EXPERIMENTAL

35 µg ethinylestradiol and 1 mg norethindrone once daily for first 21 days in each OC cycle (2 OC cycles in total) + 150 mg capsule once daily for 10 days (Day12 till and including Day21) in 2nd OC cycle

Drug: TMC435; Drug: Ovysmen

Interventions

TMC435 DRUG

Type = exact number, unit = mg, number = 150, form = capsule, route = oral use. Capsule is taken once daily for 10 days (Day12 till and including Day21) in 2nd OC cycle.

001

Ovysmen DRUG

Type = exact number, unit = mg, number = 35µg/1mg, form = tablet, route = oral use. 35 µg ethinylestradiol and 1 mg norethindrone once daily for first 21 days in each OC cycle (2 OC cycles in total)

001

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must practicing a highly effective method of birth control before entry and agree to continue to use the same method throughout the study and for at least 30 days after last administration of study drug
• non-smoker for a least 3 months prior to screening

You may not qualify if:

• Women who are pregnant, breastfeeding, pre-menopausal or post-menopausal
• A positive Human Immunodeficiency Virus (HIV)-1 or HIV-2 test at screening
• A positive Hepatitis A, B and C test at screening
• A clinical significant abnormal finding in the gynaecological examination

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Simeprevir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Tibotec Pharmaceuticals, Ireland Clinical Trial

  Tibotec Pharmaceuticals, Ireland

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 21, 2011
• First Posted: December 6, 2011
• Study Start: November 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 31, 2013

Record last verified: 2013-01

Locations

BE (1)