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

• ClinicalTrials.gov Identifier: NCT04018274
• Recruitment Status: Completed
• First Posted: July 12, 2019
• Last Update Posted: November 15, 2019
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: July 11, 2019
• First Posted Date: July 12, 2019
• Last Update Posted Date: November 15, 2019
• Actual Study Start Date: August 9, 2019
• Actual Primary Completion Date: October 16, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 11, 2019)

• 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
• 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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of PF-06651600 on the Pharmacokinetics of Oral Contraceptive Steroids
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

• 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

Study Arms

• 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.
  Interventions:

  • Drug: PF-06651600
  • Drug: Ethinyl estradiol (EE) and levonorgestrel(LN)
• 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.
  Interventions:

  • Drug: PF-06651600
  • Drug: Ethinyl estradiol (EE) and levonorgestrel(LN)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 13, 2019): 29
• Original Estimated Enrollment (submitted: July 11, 2019): 28
• Actual Study Completion Date: October 16, 2019
• Actual Primary Completion Date: October 16, 2019 (Final data collection date for primary outcome measure)

Eligibility 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 -

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04018274
• Other Study ID Numbers: B7981035
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

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.

• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: November 2019