Effect Of Multiple Dose PF-06700841 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids

NCT04267250 | Completed Phase 1 FDA Drug

• 2 other identifiers: B7931018Oral Contraceptive DDI
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

This Phase 1 study will assess the pharmacokinetic effect of multiple doses PF 06700841 (administered once a day) on a single dose of a combination oral contraceptive, in 18 healthy female participants who are not of childbearing potential.

Conditions

Healthy Female Volunteers

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), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post OC dose in periods 1 and 2

• 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), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post OC dose in periods 1 and 2

Study Arms (2)

Sequence 1

EXPERIMENTAL

In 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-06700841 PO for 13 days with a single dose of OC administered on the morning of day 10.

Drug: PF-06700841; Drug: Ethinyl estradiol (EE) and levonorgestrel (LN)

Sequence 2

EXPERIMENTAL

In sequence 2, period 1, participants will receive PF-06700841 PO for 13 days with a single dose of OC administered on the morning of day 10. After a wash-out period of at least 10 days, participants will continue into period 2 where they will receive an additional single dose of OC.

Drug: PF-06700841; Drug: Ethinyl estradiol (EE) and levonorgestrel (LN)

Interventions

PF-06700841 DRUG

60 mg by mouth (PO) once daily (QD).

Sequence 1; Sequence 2

Ethinyl estradiol (EE) and levonorgestrel (LN) DRUG

Oral tablet containing 30 mcg EE and 150 mcg LN.

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy females aged 18-60
• Not of childbearing potential
• Body mass index of 17.5-30.5 kg/m2
• Body weight \> 50 kg
• Capable of giving signed informed consent

You may not qualify if:

• Evidence or history of clinically significant disease including irritable bowel disease; HIV; Hep B and Hep C; acute or chronic infection history; lymphoproliferative disorder; tuberculosis; hearing loss; sensitivity to heparin or heparin-induced thrombocytopenia
• Any condition affecting drug absorption
• Participants who have experienced major trauma or surgery in the 3 months prior to baseline
• Participants in imminent need for surgery
• Use of prescription or non-prescription drugs within 7 days or 5 half-lives prior to dosing
• Previous administration with an investigational drug within 30 days or 5 half-lives prior to dosing
• A positive urine drug test
• Hypertension
• ECG anomalies
• Significant laboratory anomalies
• History of drug abuse with less than 6 months of abstinence prior to the baseline visit
• History of alcohol abuse within 6 months of screening
• History of nicotine use within 30 days of baseline visit
• Any contraindications to OC
• History of discontinued use of OC for medical reasons

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

PF-06700841; Ethinyl Estradiol; Levonorgestrel

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; Norgestrel; Norpregnenes

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: August 24, 2020
• Primary Completion: November 6, 2020
• Study Completion: November 6, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)