drugset / Trial / NCT04714554
A Study of the Effects of Erythromycin on the Pharmacokinetics of Relugolix, Estradiol, and Norethindrone in Healthy Postmenopausal Women and on the Pharmacokinetics of Relugolix in Healthy Adult Men
Non-randomizedCrossoverOpen-labelTreatment
Summary
This is a two-part, open-label, fixed-sequence, two-period crossover drug interaction study to assess the potential effects of erythromycin on the pharmacokinetics of relugolix, estradiol (E2), and norethindrone (NET) in healthy postmenopausal women (Part 1) and the pharmacokinetics of relugolix in healthy adult men (Part 2).
Timeline
- Start
- 2021-01-06
- Primary completion
- 2021-03-29
- Completion
- 2021-03-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erythromycin | Small molecule | 500 mg | Oral |
| Subject | Estradiol | Other / unclassified | 1 mg | Oral |
| Subject | Norethindrone | Unknown | 0.5 mg | Oral |
| Subject | Relugolix | Small molecule | 40 mg | Oral |
| Subject | Relugolix | Small molecule | 120 mg | Oral |
Indications
No indication recorded.