Evaluate the Pharmacokinetics of a Combined Oral Contraceptive (COC) With and Without Obicetrapib
NCT06250205 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2024-09-19
Summary
A study to evaluate the impact of Obicetrapib on the PK levels of Drospirenone and Ethinyl Estradiol (COC) in 30 adult female, healthy volunteers.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
Obicetrapib
oral administration
- DRUG
-
Obicetrapib + Drospirenone / Ethinyl Estradiol (COC)
oral administration
- DRUG
-
Drospirenone / Ethinyl Estradiol (COC)
oral administration
Sponsors & Collaborators
-
Novum
collaborator INDUSTRY -
NewAmsterdam Pharma
lead INDUSTRY
Principal Investigators
-
Kent A Swaine · Novum Pharmaceutical Research Services, Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 35 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-02-05
- Primary Completion
- 2024-04-25
- Completion
- 2024-04-26
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study To Estimate The Effect of PF-06650833 On The Pharmacokinetics (PK) of Oral Contraceptive (OC)
NCT05064332 ·Status: COMPLETED ·Phase: PHASE1
-
Determine the Effects of C-administration of AZD7325 and an Oral Contraceptive in Healthy Female Subjects
NCT00901290 ·Status: SUSPENDED ·Phase: PHASE1
-
Drug Interaction Oral Contraceptive Pill (OCP)
NCT01063023 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Possible Effects of Taking Mirabegron While Taking a Contraceptive Pill
NCT01297179 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Evacetrapib in Healthy Female Participants
NCT01746732 ·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
-
Effect Of Multiple Dose PF-06700841 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids
NCT04267250 ·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
-
Desogestrel-containing COCP Pharmacokinetic Validation Study
NCT05002738 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluate the Effect of VI-0521 on the Pharmacokinetics of Oral Contraceptive in Healthy Female Subjects
NCT00821496 ·Status: COMPLETED ·Phase: PHASE1
-
A Pharmacokinetic Study of Colchicine With an Oral Contraceptive
NCT01040845 ·Status: COMPLETED ·Phase: PHASE1
-
CP-690,550 And Oral Contraception Drug-Drug Interaction Study
NCT01137708 ·Status: COMPLETED ·Phase: PHASE1
-
A Study To Evaluate The Effect Of GW876008 On The Pharmacokinetics Of Oral Contraceptive Pills
NCT00508911 ·Status: TERMINATED ·Phase: PHASE1
-
A Drug Interaction Study of BIIB074 and an Oral Contraceptive Regimen
NCT03324685 ·Status: COMPLETED ·Phase: PHASE1
-
Drug-drug Interaction Study: Influence of Vilaprisan on Pharmacodynamics (PD) and Pharmacokinetics (PK) of a Combined Oral Contraceptive (COC)
NCT03210246 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Determine the Effects of PF-04965842 on the Pharmacokinetics of Oral Contraceptive Steroids in Healthy Female Subjects
NCT03662516 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Evobrutinib on Pharmacokinetics of a Combined Oral Contraceptive
NCT07215806 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Tipranavir and Ritonavir on the Pharmacokinetic Characteristics of Norethindrone-Ethinyl Estradiol in Healthy Female Adult Volunteers
NCT02245438 ·Status: TERMINATED ·Phase: PHASE1
-
A Study of Lanabecestat in Healthy Female Participants Taking Oral Contraceptive
NCT03506399 ·Status: WITHDRAWN ·Phase: PHASE1
-
A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With GSK3036656 in Female Participants of Non-childbearing Potential Aged 18 to 65 Years of Age
NCT06354257 ·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
-
A Study to Investigate the Pharmacokinetics of Ethinyl Estradiol and Levonorgestrel When Given Alone and in Combination With Baxdrostat in Healthy Females of Non-childbearing Potential
NCT06657105 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives
NCT01291004 ·Status: COMPLETED ·Phase: PHASE1
-
Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive
NCT00196326 ·Status: COMPLETED ·Phase: PHASE3
-
Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive
NCT00362479 ·Status: COMPLETED ·Phase: PHASE3