STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS
NCT05093205 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2024-08-19
Summary
The purpose of this study is to characterize the effect of PF-06882961, administered at 2 steady-state dose levels, on the PK of single doses of atorvastatin (20 mg) or midazolam (5 mg), administered separately, in healthy adult male and female participants (Part A), or an OC in healthy PM female participants (Part B).
Conditions
- Healthy Adults
Interventions
- DRUG
-
PF-06882961
Tablets
- DRUG
-
Tablets
- DRUG
-
Midazolam
Syrup
- DRUG
-
Levonorgestrel & Ethinyl Estradiol
Tablet
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-10-25
- Primary Completion
- 2022-07-06
- Completion
- 2022-07-06
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Assessing the Effect of Multiple Doses of Zibotentan on the Pharmacokinetics of Single Doses of Combined Oral Contraceptives in Healthy Female Participants of Non-childbearing Potential.
NCT05505162 ·Status: COMPLETED ·Phase: PHASE1
-
A Drug-drug Interaction Study to Investigate the Effect of Coadministration of EDP-305 on the PK of a Combined Oral Contraceptive in Healthy Female Subjects
NCT03783897 ·Status: COMPLETED ·Phase: PHASE1
-
A Study To Estimate The Effect of PF-06650833 On The Pharmacokinetics (PK) of Oral Contraceptive (OC)
NCT05064332 ·Status: COMPLETED ·Phase: PHASE1
-
Phase II Study of Ovulation in Obese Women
NCT06306131 ·Status: RECRUITING ·Phase: PHASE2
-
Norethindrone for the Delay of Menstruation
NCT03594604 ·Status: COMPLETED ·Phase: PHASE4
-
Effect of Multiple BI 1356 Doses of on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Female Premenopausal Subjects
NCT02175394 ·Status: COMPLETED ·Phase: PHASE1
-
A Drug-drug Interaction Study to Investigate the Effects of AZD1981 on the Metabolism and Pharmacodynamics of Oral Contraceptives
NCT01110525 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluate the Effect of VI-0521 on the Pharmacokinetics of Oral Contraceptive in Healthy Female Subjects
NCT00821496 ·Status: COMPLETED ·Phase: PHASE1
-
An Open-label Study in Healthy Participants to Evaluate AZD0780 as an Object or Precipitant of CYP3A4-mediated Drug-drug Interactions
NCT06671405 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Lanabecestat in Healthy Female Participants Taking Oral Contraceptive
NCT03506399 ·Status: WITHDRAWN ·Phase: PHASE1
-
Study in Women on the Effect of JNJ-64530440 on Oral Contraceptive and Midazolam, and the Effect of a High-fat Meal on JNJ-64530440
NCT03890341 ·Status: WITHDRAWN ·Phase: PHASE1
-
CP-690,550 And Oral Contraception Drug-Drug Interaction Study
NCT01137708 ·Status: COMPLETED ·Phase: PHASE1
-
Effect Of Multiple Dose PF-06700841 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids
NCT04267250 ·Status: COMPLETED ·Phase: PHASE1
-
Drug Interaction Oral Contraceptive Pill (OCP)
NCT01063023 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea
NCT00196391 ·Status: COMPLETED ·Phase: PHASE2
-
Drug-drug Interaction Study: Influence of Vilaprisan on Pharmacodynamics (PD) and Pharmacokinetics (PK) of a Combined Oral Contraceptive (COC)
NCT03210246 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate Effect of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination on the Pharmacokinetics of a Representative Hormonal Contraceptive Medication, Norgestimate/Ethinyl Estradiol
NCT02533427 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Healthy Female Participants to Investigate the Effect of JNJ-56136379 at Steady-state on the Single-dose Pharmacokinetics of Ethinylestradiol and Drospirenone (Oral Contraceptive) and on the Single-dose Pharmacokinetics of Midazolam (Probe Substrate for Cytochrome P450 3A4)
NCT03111511 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Effect of Multiple Oral Doses of JNJ-42847922 on the Steady-state Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel in Healthy Female Adult Participants
NCT03249402 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacodynamics of NPC-01/IKH-01; Effect of NPC-01/IKH-01 on Sexual Hormone Concentrations in Healthy Female Volunteers
NCT01253824 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase I Study to Evaluate the PK and PD of a Single Injection of Levonorgestrel Butanoate for Female Contraception
NCT02173808 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Norgestrel 75 mcg on Cervical Mucus and Ovarian Activity During Perfect Use, After One Delayed Intake and After a Missed Pill
NCT03585712 ·Status: COMPLETED ·Phase: PHASE2
-
A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects
NCT00549666 ·Status: COMPLETED ·Phase: PHASE1
-
Oral Levonorgestrel Plus Meloxicam, IG-002 Delays Ovulation in Normal Menstruating Women by Seven Days
NCT05695352 ·Status: RECRUITING ·Phase: PHASE2
-
Metabolism of 0.35mg Norethindrone vs 5mg Norethindrone Acetate
NCT05294341 ·Status: COMPLETED ·Phase: PHASE4