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.

Conditions

• Healthy Female Participants

Eligibility Criteria

Sex

FEMALE

Age

35 Years - 75 Years

Healthy Volunteers

Accepted

Interventions

• Zibotentan — DRUG
  Participants will receive two capsules of Zibotentan orally QD from day 6-19.
• EE/LNG — DRUG
  Participants will receive two tablets of EE and LNG once on Day 1 and Day 15 as a combined oral dose.

Study Details

A study to assess the Pharmacokinetics (PK) of combined oral ethinyl estradiol (EE) and levonorgestrel (LNG) in healthy female participants of non-child-bearing potential, when administered alone and in combination with multiple oral doses of zibotentan.

Key Dates

Start date

Aug 24, 2022

Status verified

Feb 2023

Primary completion

Jan 10, 2023

Completion

Jan 10, 2023

Study Design

Enrollment

24 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Zibotentan and EE/LNG
  Participants will receive two tablets of combined oral EE/LNG on Day 1 with PK samples obtained from pre-dose on Day 1 until post-dose on Day 6. Participants will receive two capsules of zibotentan orally QD from Day 6 to Day 14. From Day 15 until Day 19 participants will continue to receive two capsules of zibotentan QD administered orally. On Day 15, participants will receive two tablets of combined oral EE and LNG with PK samples obtained pre-dose on Day 15 until post-dose (Day 20).

Primary Outcome Measure

Area under plasma concentration time curve from zero to infinity (AUCinf) [ Time Frame: Day 1 and Day 15 ]

Locations (1)

Find similar trials in Brooklyn, MD