A Drug Drug Interaction Study Between PF-06826647 And Oral Contraceptive Steroids In Healthy Female Participants
NCT04134715
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 1. Healthy female participants of non-childbearing potential must be 18 to 60 years of age, inclusive
- 2. Female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, including blood pressure (BP) and pulse rate measurement, laboratory tests, and 12 lead ECG
- 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 30.5 kg/m2; and a total body weight >50 kg (110 lb)
- 1. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, 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).
- 3. History of venous and arterial thrombosis (ie, deep venous thrombosis, pulmonary
embolism) or hereditary clotting disorders (in first degree immediate relatives).
- 4. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis
C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C
antibody (HCVAb). Hepatitis B vaccination is allowed.
- 5. Any current evidence of untreated active or latent or inadequately treated
infection with Mycobacterium tuberculosis (TB).
- 6. Participants who use tobacco or nicotine containing products.
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| Descriptive Information | |||||||
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| Brief Title ICMJE | A Drug Drug Interaction Study Between PF-06826647 And Oral Contraceptive Steroids In Healthy Female Participants | ||||||
| Official Title ICMJE | A PHASE 1, RANDOMIZED, OPEN LABEL, FIXED SEQUENCE STUDY TO ESTIMATE THE EFFECT OF PF-06826647 ON THE PHARMACOKINETICS OF ORAL CONTRACEPTIVE STEROIDS AND TO ESTIMATE THE EFFECT OF ORAL CONTRACEPTIVE STEROIDS ON PHARMACOKINETICS OF PF-06826647 IN HEALTHY FEMALE PARTICIPANTS | ||||||
| Brief Summary | This is a Phase 1, fixed sequence, multiple dose, open label study of the effect of PF-06826647 on oral contraceptive (OC) pharmacokinetics (PK) and vice versa in healthy female participants. A total of approximately 15 healthy female participants will be enrolled and dosed to achieve at least 12 participants completing the study. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 1 | ||||||
| Study Design ICMJE | Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Other | ||||||
| Condition ICMJE | Healthy | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE | Experimental: PF-06826647 alone then OC alone then OC+PF-06826647
In Period 1 (Period 1 is 2 days), participants will receive a single dose of PF-06826647 600 mg on Day 1. Period 2 (Period 2 is 14 days) will immediately follow Period 1 without any washout. In Period 2, the participants will receive OC in the form of 1 PORTIA (30 µg EE and 150 µg LN) or equivalent tablet, orally starting from Period 2 Day 1 until Period 3-Day 16 (Period 3 is 17 Days). Period 3 will immediately follow Period 2 with no washout. In Period 3 on Day 1, the participants will receive a single dose of PF-06826647 600 mg. On Day 2 in Period 3, PF-06826647 will not be dosed. From Day 3, the participants will receive PF-06826647 600 mg QD for 14 days followed by OC in the form of 1 PORTIA (EE and LN) or equivalent tablet. Interventions:
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| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE | 15 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Actual Study Completion Date ICMJE | January 9, 2020 | ||||||
| Actual Primary Completion Date | January 9, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 60 Years (Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT04134715 | ||||||
| Other Study ID Numbers ICMJE | C2501005 | ||||||
| Has Data Monitoring Committee | Not Provided | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Pfizer | ||||||
| Verification Date | February 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||