A STUDY TO ESTIMATE THE EFFECT OF PF-06651600 ON THE PHARMACOKINETICS (PK) OF ORAL CONTRACEPTIVE (OC)

NCT03608241 | Completed Phase 1 FDA Drug

• 1 other identifier: B7981018
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase 1, randomized, 2 way crossover, multiple dose, open label study of the effect of multiple dose PF-06651600 on single dose OC PK in healthy female subjects. Subjects will be randomized to 1 of 2 treatment sequences.

Conditions

Healthy Females

Keywords

female; post-menopausal; healthy; oral contraceptive

Outcome Measures

Primary Outcomes (2)

• Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for EE

  AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).

  0 (pre-dose),1, 1.5. 2,4,6,8,12,24 and 48 hours post-dose

• Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for LN

  AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).

  0 (pre-dose), 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours post-dose

Secondary Outcomes (4)

• Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

  Baseline (Day 0) up to 28 days after last dose of study drug

• Number of Adverse Events by Severity

  Baseline up to 28 days after last dose

• Number of Participants With Categorical Vital Signs Data

  Baseline through study completion, approximately 23 days.

• Number of Participants With Change From Baseline in Laboratory Tests Results

  Baseline through study completion, approximately 23 days.

Study Arms (2)

Treatment sequence 1

EXPERIMENTAL

Treatment sequence 1 will receive a single dose of an oral contraceptive during the first period of the study (period 1) and then continue to the second period (Period 2) of the study where they will receive PF-06651600 every day for 11 days and a single dose of an oral contraceptive towards the end of the period.

Drug: PF-06651600; Drug: Ethinyl estradiol (EE) and levonogestrel (LN)

Treatment Sequence 2

EXPERIMENTAL

Treatment sequence 2 will receive PF-06651600 every day for 11 days during the first period of the study (period 1) and a single dose of an oral contraceptive towards the end of this period. After completion of Period 1, there will be a washout period of at least 10 days before starting the second period of the study (period 2). During period 2, a single dose of an oral contraceptive will be received.

Drug: PF-06651600; Drug: Ethinyl estradiol (EE) and levonogestrel (LN)

Interventions

PF-06651600 DRUG

200 mg by mouth (PO) Once daily (QD) for 11 days

Treatment Sequence 2; Treatment sequence 1

Ethinyl estradiol (EE) and levonogestrel (LN) DRUG

Single dose of Oral tablet containing 30 ug EE and 150 ug of LN

Also known as: Oral contraceptive

Treatment Sequence 2; Treatment sequence 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Healthy female subjects of non childbearing potential
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female subjects of non childbearing potential
• Female subjects of non childbearing potential must meet at least 1 of the following criteria:
• Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state;
• Have undergone a documented hysterectomy and/or bilateral oophorectomy;
• Have medically confirmed ovarian failure. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential and are not eligible for this study.
• Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight \>50 kg (110 lb).

You may not qualify if:

• Subjects with any of the following characteristics/conditions will not be included in the study:
• 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).
• History of drug abuse with less than 6 months of abstinence prior to the baseline visit.
• History of regular alcohol consumption exceeding 7 drinks/week for female subjects (1 drink = 5 ounces \[150 mL\] of wine or 12 ounces \[360 mL\] of beer or 1.5 ounces \[45 mL\] of hard liquor) within 6 months before screening.
• Any medical reason which would contraindicate the administration of oral contraceptives (as per the label) or history of discontinued use of oral contraceptives due to medical reasons.
• Subjects with a known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.
• Subjects who have a malignancy or a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
• Any current evidence of untreated active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).
• History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Quotient Sciences

Coral Gables, Florida, 33134, United States

Location

Quotient Sciences-Miami, Inc.

Miami, Florida, 33126, United States

Location

Related Links

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

MeSH Terms

Interventions

PF-06651600; Ethinyl Estradiol; Contraceptives, Oral

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 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
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: July 31, 2018
• Study Start: September 21, 2018
• Primary Completion: November 23, 2018
• Study Completion: November 23, 2018
• Last Updated: April 9, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)