NCT01486004

A Phase-I, Open-label Trial in Healthy Female Subjects to Investigate the Effect of TMC435 at Steady-state on the Steady-state Pharmacokinetics of Ethinylestradiol and Norethindrone

Completed Phase 1 Last updated 30 January 2013

What this trial tests

Phase 1 trial testing TMC435 in Hepatitis C Virus in 18 participants. Completed in 1 January 2012.

Timeline

1 November 2011

Primary endpoint
1 January 2012

1 January 2012

Quick facts

Lead sponsor	Tibotec Pharmaceuticals, Ireland
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	1 November 2011
Primary completion	1 January 2012
Estimated completion	1 January 2012
Sites	1 location across Belgium

Drugs / interventions tested

• TMC435 — full drug profile →
• Ovysmen — full drug profile →

Conditions studied

• Hepatitis C Virus — all drugs for Hepatitis C Virus →

Sponsor

Tibotec Pharmaceuticals, Ireland — full company profile →

Who can join

Adults 18 to 45, female only, with Hepatitis C Virus. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in the steady-state plasma PK of ethinylestradiol following co-administration with TMC435
  Time frame: Measured on Day19 till and including Day22 of 2nd OC cycle. Reference is Day19 till and including Day22 of 1st OC cycle.
  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.
• Change in the steady-state plasma PK of norethindrone following co-administration with TMC435
  Time frame: Measured on Day19 till and including Day22 of 2nd OC cycle. Reference is Day19 till and including Day22 of 1st OC cycle.
  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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.