Effect of Tipranavir and Ritonavir on the Pharmacokinetic Characteristics of Norethindrone-Ethinyl Estradiol in Healthy Female Adult Volunteers
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Tipranavir low dose (Drug); Tipranavir high dose (Drug); Ritonavir low dose (Drug); Ritonavir high dose (Drug); Norethindrone-Ethinyl Estradiol (Drug)
Phase: Phase 1
Status: Terminated
Sponsored by: Boehringer Ingelheim
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.
Clinical Details
Official title: A Single Centre, Open-label, Randomized, Parallel Group, Multiple Dose Comparison of the Effect of TPV 750 mg and RTV 200 mg or TPV 500 mg and RTV 100 mg, Administered Twice Daily, on the Pharmacokinetic Characteristics of Norethindrone-Ethinyl Estradiol (Ortho®-1/35 ) Administered as a Single Dose, in Healthy Female Adult Volunteers.
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Area under plasma concentration time curveMaximum plasma concentration of the analyte Drug concentration of the analyte in plasma at 12 hours after administration
Secondary outcome: Oral clearance of the analyteTime of maximum concentration of the analyte Apparent terminal half life of the analyte Number of subjects with adverse events Number of subject with clinically relevant changes in laboratory parameters
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
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
Locations and Contacts
Additional Information
Starting date: May 2002
Last updated: September 18, 2014
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