A Drug Drug Interaction Study Between PF-06826647 And Oral Contraceptive Steroids In Healthy Female Participants

NCT04134715 | Completed Phase 1 FDA Drug

• 1 other identifier: C2501005
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Keywords

Oral contraceptive; Drug-Drug Interaction (DDI); PF-06826647

Outcome Measures

Primary Outcomes (4)

• Area Under the Plasma Concentration-Time Profile From Time Zero To End of Dosing Interval (AUGtau) of Ethinyl Estradiol (EE)

  Area under the plasma concentration time profile from time 0 to end of dosing interval (AUCtau), where dosing interval is 24 hours.

  Day 14 in Period 2 (Period 2 is 14 days) and Day 16 in Period 3 (Period 3 is 17 days)

• Area Under the Plasma Concentration-Time Profile From Time Zero To End of Dosing Interval (AUGtau) of Levonorgestrel (LN)

  Area under the plasma concentration time profile from time 0 to end of dosing interval (AUCtau), where dosing interval is 24 hours.

  Day 14 in Period 2 (Period 2 is 14 days) and Day 16 in Period 3 (Period 3 is 17 days)

• Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06826647

  AUCinf is calculated by AUClast + (Clast\*/kel), where AUClast is the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

  Day 1 in Period 1 (Period 1 is 2 days) and Period 3 (Period 3 is 17 days)

• Maximum Plasma Concentration (Cmax) of PF-06826647

  Cmax will be observed directly from data.

  Day 1 in Period 1 (Period 1 is 2 days) and Period 3 (Period 3 is 17 days)

Secondary Outcomes (6)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Baseline in Period 1 (Period 1 is 2 days) to Day 17 in Period 3 (Period 3 is 17 days)

• Number of Participants With Clinically Significant Change From Baseline in Vital Signs

  Baseline in Period 1 (Period 1 is 2 days) to Day 17 in Period 3 (Period 3 is 17 days)

• Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Hematology

  Baseline in Period 1 (Period 1 is 2 days) to Day 17 in Period 3 (Period 3 is 17 days)

• Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Clinical Chemistry

  Baseline in Period 1 (Period 1 is 2 days) to Day 17 in Period 3 (Period 3 is 17 days)

• Number of Paticipants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Urinalysis

  Baseline in Period 1 (Period 1 is 2 days) to Day 17 in Period 3 (Period 3 is 17 days)

Study Arms (1)

PF-06826647 alone then OC alone then OC+PF-06826647

EXPERIMENTAL

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.

Drug: PF-06826647; Drug: Oral Contraceptive (OC)

Interventions

PF-06826647 DRUG

100 mg tablet

PF-06826647 alone then OC alone then OC+PF-06826647

Oral Contraceptive (OC) DRUG

OC in the form of 1 PORTIA (30 µg EE and 150 µg LN) or equivalent tablet

PF-06826647 alone then OC alone then OC+PF-06826647

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Women of non-child bearing potential
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Healthy female participants of non-childbearing potential must be 18 to 60 years of age, inclusive
• \. 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
• \. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
• \. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb)

You may not qualify if:

• \. 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).
• \. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
• \. History of venous and arterial thrombosis (ie, deep venous thrombosis, pulmonary embolism) or hereditary clotting disorders (in first degree immediate relatives).
• \. 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.
• \. Any current evidence of untreated active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).
• \. Participants who use tobacco or nicotine containing products.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Quotient Sciences Screening Office

Coral Gables, Florida, 33134, United States

Location

Quotient Sciences-Miami

Miami, Florida, 33126, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

ropsacitinib; Contraceptives, Oral

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: October 22, 2019
• Study Start: October 23, 2019
• Primary Completion: January 9, 2020
• Study Completion: January 9, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)