Effect of Tipranavir and Ritonavir on the Pharmacokinetic Characteristics of Norethindrone-Ethinyl Estradiol in Healthy Female Adult Volunteers

NCT02245438 | Terminated Phase 1

• 1 other identifier: 1182.22
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to characterize the effects of two dose combinations of Tipranavir (TPV)/Ritonavir (RTV) (TPV 750 mg/RTV 200 mg and TPV 500 mg/RTV 100 mg), administered twice-daily, on the pharmacokinetics of Norethindrone-Ethinyl Estradiol (NET/EE) 1 mg/ 0.035 mg administered as a single dose.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Area under plasma concentration time curve

  up to day 17

• Maximum plasma concentration of the analyte

  up to day 17

• Drug concentration of the analyte in plasma at 12 hours after administration

  up to day 17

Secondary Outcomes (5)

• Oral clearance of the analyte

  up to day 17

• Time of maximum concentration of the analyte

  up to day 17

• Apparent terminal half life of the analyte

  up to day 17

• Number of subjects with adverse events

  up to 45 days

• Number of subject with clinically relevant changes in laboratory parameters

  up to 17 days

Study Arms (2)

TPV/RTV low dose

EXPERIMENTAL

Drug: Tipranavir low dose; Drug: Ritonavir low dose; Drug: Norethindrone-Ethinyl Estradiol

TPV/RTV high dose

EXPERIMENTAL

Drug: Tipranavir high dose; Drug: Ritonavir high dose; Drug: Norethindrone-Ethinyl Estradiol

Interventions

Tipranavir low dose DRUG

TPV/RTV low dose

Tipranavir high dose DRUG

TPV/RTV high dose

Ritonavir low dose DRUG

Also known as: Norvir-SEC®

TPV/RTV low dose

Ritonavir high dose DRUG

Also known as: Norvir-SEC®

TPV/RTV high dose

Norethindrone-Ethinyl Estradiol DRUG

Also known as: Ortho®-1/35

TPV/RTV high dose; TPV/RTV low dose

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female subjects between 18 and 50 years of age inclusive
• A Body Mass Index (BMI) between 18 and 29 kg/m2
• Signed informed consent prior to trial participation
• Ability to swallow numerous large capsules without difficulty
• Acceptable laboratory values that indicate adequate baseline organ function are required at the time of screening. Laboratory values are considered to be acceptable if severity is less than or equal to Grade 1, based on the AIDS Clinical Trials Group Grading Scale. All abnormal laboratory values greater than Grade 1 are subject to approval by the trial clinical monitor.
• Acceptable medical history, physical examination and ECG, and chest X-ray (if not conducted within the last 12 months) are required prior to entering the treatment phase of the study
• Willingness to abstain from alcohol for 48 hours prior to Study Day 0 and abstain from alcohol for the duration of the study. In addition, red wine must not have been ingested within 5 days prior to Day 0 (Visit 2)
• Willingness to abstain from ingesting grapefruit, grapefruit juice, or products containing grapefruit juice, within 10 days before Day 0, Visit 2 and for the duration of the study
• Willingness to abstain from ingesting Seville oranges, garlic supplements, St. John's Wort, Milk Thistle, or methylxanthine-containing drinks or food (coffee, tea, cola, energy drinks, chocolate, etc) within 5 days of Day 0, Visit 2 and for the duration of the study
• Willingness to abstain from over the counter herbal medications for the duration of the study
• Reasonable probability for completion of the study

You may not qualify if:

• Female subjects who are of reproductive potential who:
• Have positive serum beta-human chorionic gonadotropin at Visit 1, or on Day 0 or Day 1
• Have not been using a barrier contraceptive method for at least 3 months prior to Visit 3 (Day 1)
• Are not willing to use a reliable method of double-barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during the trial and 30 days after completion/termination
• Are breast-feeding
• Participation in another trial with an investigational medicine within 30 days prior to Day 0 (Visit 2)
• Use of any medication listed in the protocol within 30 days prior to Day 0 (Visit 2)
• Use of any other pharmacological contraceptive (including oral, patch or injectable contraceptives) for 1 month prior to study initiation and for the duration of the study
• Administration of antibiotics within 10 days prior to Day 0 (Visit 2) or during the trial
• History of central nervous system (CNS), gastrointestinal, hepatic, or renal disorders within the past sixty (60) days. Subjects will be excluded for these disorders greater than sixty days if, in the opinion of the investigator, the subject does not qualify as a healthy volunteer
• History of thrombotic disease
• History of migraine headache
• Have serological evidence of hepatitis B or C virus
• Have serological evidence of exposure to HIV
• Recent history of alcohol or substance abuse (within 6 months of study period)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

tipranavir; Ritonavir; ovcon 35

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 19, 2014
• Study Start: May 1, 2002
• Primary Completion: June 1, 2002
• Last Updated: September 19, 2014

Record last verified: 2014-09