Clinical trial NCT04134715: A Drug Drug Interaction Study Between PF-06826647 And Oral Contraceptive Steroids In Healthy Female Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Oral contraceptive
Drug-Drug Interaction (DDI)
PF-06826647
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-10-22
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Area Under the Plasma Concentration-Time Profile From Time Zero To End of Dosing Interval (AUGtau) of Ethinyl Estradiol (EE)
timeFrame: Day 14 in Period 2 (Period 2 is 14 days) and Day 16 in Period 3 (Period 3 is 17 days)
measure: Area Under the Plasma Concentration-Time Profile From Time Zero To End of Dosing Interval (AUGtau) of Levonorgestrel (LN)
timeFrame: Day 14 in Period 2 (Period 2 is 14 days) and Day 16 in Period 3 (Period 3 is 17 days)
measure: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06826647
timeFrame: Day 1 in Period 1 (Period 1 is 2 days) and Period 3 (Period 3 is 17 days)
measure: Maximum Plasma Concentration (Cmax) of PF-06826647
timeFrame: Day 1 in Period 1 (Period 1 is 2 days) and Period 3 (Period 3 is 17 days)
Secondary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Baseline in Period 1 (Period 1 is 2 days) to Day 17 in Period 3 (Period 3 is 17 days)
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
timeFrame: Baseline in Period 1 (Period 1 is 2 days) to Day 17 in Period 3 (Period 3 is 17 days)
measure: Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Hematology
timeFrame: Baseline in Period 1 (Period 1 is 2 days) to Day 17 in Period 3 (Period 3 is 17 days)
measure: Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Clinical Chemistry
timeFrame: Baseline in Period 1 (Period 1 is 2 days) to Day 17 in Period 3 (Period 3 is 17 days)
measure: Number of Paticipants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Urinalysis
timeFrame: Baseline in Period 1 (Period 1 is 2 days) to Day 17 in Period 3 (Period 3 is 17 days)
measure: Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
timeFrame: Baseline (Period 1 Day 1), Day 1 (Period 1 and Period 2) up to Day 17 (Period 3)
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Quotient Sciences Screening Office
state: Florida
city: Miami
country: United States
facility: Quotient Sciences-Miami
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: