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Completed

NCT Number: NCT04134715

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

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences Screening Office, Coral Gables, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-06826647

Drug

100 mg tablet

Oral Contraceptive (OC)

Drug

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

Primary outcomes

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

    Time frame: 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 0 to end of dosing interval (AUCtau), where dosing interval is 24 hours.

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

    Time frame: 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 0 to end of dosing interval (AUCtau), where dosing interval is 24 hours.

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

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

    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.

  4. Maximum Plasma Concentration (Cmax) of PF-06826647

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

    Cmax will be observed directly from data.

Secondary outcomes

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

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

    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs. TEAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment.

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

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

    Vital signs evaluation includes: supine systolic and diastolic blood pressure (BP), and pulse rate.

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

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

    Hematology evaluation includes: hemoglobin, hematocrit, red blood cell (RBC) count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelets, white blood cell count (WBC), neutrophils, eosinophils, monocytes, basophils, lymphocytes and reticulocytes.

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

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

    Clinical chemistry evaluation includes: blood urea nitrogen, creatinine, fasting glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, bilirubin, alkaline phosphatase, urate, albumin, protein, creatinine kinase

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

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

    Urinalysis evaluation includes: qual urine glucose, qual protein, qual blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, urine leukocytes.

  6. Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings

    Time frame: Baseline (Period 1 Day 1), Day 1 (Period 1 and Period 2) up to Day 17 (Period 3)

    Criteria for clinically significant changes in ECG (12-lead) are defined as: a postdose QTc interval increase by ≥30 msec from the baseline and is >450 msec; or an absolute QTc value is ≥500 msec for any scheduled ECG

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 22, 2019
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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