AzTrials
AzTrials

HealthyPhase 1NCT02245438

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

A Phase 1 study testing Tipranavir low dose, Tipranavir high dose and Ritonavir low dose in people with Healthy, run by Boehringer Ingelheim.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Tipranavir low dose, Tipranavir high dose and Ritonavir low dose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
No sites listed yet
Study dates
May 2002to Jun 2002
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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)
Show all 23Show fewer
  • 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)
  • Cigarette smoking (greater than 10 cigarettes per day)
  • Blood or plasma donations within 30 days prior to Day 0 (Visit 2) or during the trial.
  • 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
  • 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
  • Subjects who have had an acute illness within 2 weeks prior to Day 0 (Visit 2)
  • 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
  • Known hypersensitivity to TPV, RTV, or NET/EE
  • Inability to comply with the protocol

About this study

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 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
Being tested
Tipranavir low dose, Tipranavir high dose, Ritonavir low dose, Ritonavir high dose, Norethindrone-Ethinyl Estradiol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tipranavir low doseDrug

  • Tipranavir high doseDrug

  • Ritonavir low doseDrug

    Also called Norvir-SEC®

  • Ritonavir high doseDrug

    Also called Norvir-SEC®

  • Norethindrone-Ethinyl EstradiolDrug

    Also called Ortho®-1/35

Study groups in NCT02245438
Study groupRoleWhat they receive
TPV/RTV low doseExperimentalNot described
Receives: Drug: Tipranavir low dose; Drug: Ritonavir low dose; Drug: Norethindrone-Ethinyl Estradiol
TPV/RTV high doseExperimentalNot described
Receives: Drug: Tipranavir high dose; Drug: Ritonavir high dose; Drug: Norethindrone-Ethinyl Estradiol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under plasma concentration time curve

    Measured: up to day 17

  2. Maximum plasma concentration of the analyte

    Measured: up to day 17

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

    Measured: up to day 17

Secondary outcomes (5)

  1. Oral clearance of the analyte

    Measured: up to day 17

  2. Time of maximum concentration of the analyte

    Measured: up to day 17

  3. Apparent terminal half life of the analyte

    Measured: up to day 17

  4. Number of subjects with adverse events

    Measured: up to 45 days

  5. Number of subject with clinically relevant changes in laboratory parameters

    Measured: up to 17 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2014 (estimated)
  2. Study startMay 2002
  3. Primary completionJun 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02245438
Sponsor's protocol ID
1182.22
Status last verified
Sep 2014
First submitted
18 Sep 2014
Last updated
19 Sep 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tipranavir low dose, Tipranavir high dose and Ritonavir low dose in people with Healthy, run by Boehringer Ingelheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under plasma concentration time curve (time frame: up to day 17). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02245438.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in