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Effect of PF-06651600 on the Pharmacokinetics of Oral Contraceptive Steroids

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ClinicalTrials.gov Identifier: NCT04018274
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This is a Phase 1, randomized, 2 way crossover, open-label study of the effect of multiple-dose PF 06651600 on single-dose oral contraceptive (OC) pharmacokinetics (PK) in healthy female subjects. Subjects will be randomized to 1 of 2 treatment sequences. A total of 28 healthy female subjects (14 in each treatment sequence) will be enrolled in the study. Each treatment sequence will consist of 2 periods.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-06651600 Drug: Ethinyl estradiol (EE) and levonorgestrel(LN) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A PHASE 1, RANDOMIZED, OPEN LABEL, 2 WAY CROSSOVER STUDY TO DEMONSTRATE A LACK OF AN EFFECT OF MULTIPLE DOSE PF 06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE ORAL CONTRACEPTIVE STEROIDS IN HEALTHY FEMALE PARTICIPANTS
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Arm Intervention/treatment
Experimental: Sequence 1
In Treatment Sequence 1, period 1, participants will be dosed with a single administration of oral contraceptive (OC). Participants will continue directly into Period 2 where they will receive PF-06651600 PO for 9 days followed by administration of a single dose of OC on the morning of Day 10.
Drug: PF-06651600
50 mg by mouth (PO) once daily (QD)

Drug: Ethinyl estradiol (EE) and levonorgestrel(LN)
Oral tablet containing 30 ug EE and 150 ug of LN
Other Name: Oral contraceptives

Experimental: Sequence 2
In Treatment Sequence 2, Period 1, participants will be dosed with PF-06651600 PO QD for 9 days and administered a single dose of OC on the morning of Day 10. After a washout period of at least 10 days, participants will continue into Period 2 and will receive an additional single dose of OC.
Drug: PF-06651600
50 mg by mouth (PO) once daily (QD)

Drug: Ethinyl estradiol (EE) and levonorgestrel(LN)
Oral tablet containing 30 ug EE and 150 ug of LN
Other Name: Oral contraceptives




Primary Outcome Measures :
  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for EE [ Time Frame: predose, 30 minutes and 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post OC dose in Periods 1 and 2 ]
    30 micrograms administered as oral OC combination tablet

  2. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for LN [ Time Frame: predose, 30 minutes and 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post OC dose in Periods 1 and 2 ]
    150 micrograms administered as oral OC combination tablet



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

Age and Sex:

  1. Female participants of non childbearing potential who, at the time of screening, are between the ages of 18 and 60 years, inclusive.
  2. Female participants who are healthy as determined by medical evaluation including detailed medical history, full physical examination, including blood pressure (BP) and pulse rate measurement, 12 lead ECG, or clinical laboratory tests.
  3. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  4. Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion Criteria:

  1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  2. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, appendectomy).
  3. Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first-degree relative with a hereditary immunodeficiency.
  4. Infection with hepatitis B or hepatitis C viruses -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018274


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04018274     History of Changes
Other Study ID Numbers: B7981035
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Contraceptive Agents
Levonorgestrel
Contraceptives, Oral
Estradiol
Ethinyl Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic