Overview
Effect of Tipranavir and Ritonavir on the Pharmacokinetic Characteristics of Norethindrone-Ethinyl Estradiol in Healthy Female Adult Volunteers
Status:
Terminated
Terminated
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
Female
Female
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Boehringer IngelheimTreatments:
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Norethindrone
Norethindrone Acetate
Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Norinyl
Polyestradiol phosphate
Ritonavir
Tipranavir
Criteria
Inclusion Criteria:1. Female subjects between 18 and 50 years of age inclusive
2. A Body Mass Index (BMI) between 18 and 29 kg/m2
3. Signed informed consent prior to trial participation
4. Ability to swallow numerous large capsules without difficulty
5. 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.
6. 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
7. 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)
8. 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
9. 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
10. Willingness to abstain from over the counter herbal medications for the duration of
the study
11. Reasonable probability for completion of the study
Exclusion Criteria:
1. 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
2. Participation in another trial with an investigational medicine within 30 days prior
to Day 0 (Visit 2)
3. Use of any medication listed in the protocol within 30 days prior to Day 0 (Visit 2)
4. 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
5. Administration of antibiotics within 10 days prior to Day 0 (Visit 2) or during the
trial
6. 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
7. History of thrombotic disease
8. History of migraine headache
9. Have serological evidence of hepatitis B or C virus
10. Have serological evidence of exposure to HIV
11. Recent history of alcohol or substance abuse (within 6 months of study period)
12. Cigarette smoking (greater than 10 cigarettes per day)
13. Blood or plasma donations within 30 days prior to Day 0 (Visit 2) or during the trial.
14. Subjects with a seated systolic blood pressure either <100 mm Hg or >150 mm Hg;
resting heart rate either <50 beats/min or >90 beats/min. For subjects with a resting
heart rate below 50, due to a high fitness level, the investigator may discuss
exclusion with the medical monitor on a case-by-case basis
15. Subjects with a history of any illness or allergy that, in the opinion of the
investigator, might confound the results of the study or pose additional risk in
administering Tipranavir, Ritonavir or NET/EE to the subject
16. Subjects who have had an acute illness within 2 weeks prior to Day 0 (Visit 2)
17. Subjects who are currently taking any over-the-counter drug within 7 days prior to Day
0,(Visit 2) or who are currently taking any prescription drug that, in the opinion of
the investigator in consultation with the clinical monitor, might interfere with
either the absorption, distribution or metabolism of the test substances
18. Known hypersensitivity to TPV, RTV, or NET/EE
19. Inability to comply with the protocol