Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Erythromycin · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1: Relugolix/E2/NETA Plus Erythromycin | EXPERIMENTAL | Treatment Period 1: Healthy premenopausal women will receive a relugolix/E2/NETA (40 mg/1 mg/0.5 mg) alone on Day 1. Treatment Period 2: Healthy premenopausal women will receive erythromycin on Day 1 through 12 (500 mg, QID), with co-administration of a single dose of relugolix/E2/NETA (40 mg/1 mg/0.5 mg) with the morning dose of erythromycin on Day 8. |
| Part 2: Relugolix Plus Erythromycin | EXPERIMENTAL | Treatment Period 1: Male participants will receive a single 120-mg dose of relugolix alone on Day 1. Treatment Period 2: Male participants will receive erythromycin on Days 1 through 12 (500 mg, QID), with co-administration of a single 120-mg dose of relugolix with the morning dose of erythromycin on Day 8. |
| Name | Type | Description |
|---|---|---|
| Relugolix/E2/NETA FDC | DRUG | Relugolix/E2/NETA (40 mg/1 mg/0.5 mg) FDC tablet; oral administration. |
| Relugolix | DRUG | Relugolix 120-mg tablets; oral administration. |
| Erythromycin | DRUG | Erythromycin 500-mg tablets; oral administration. |
Key Inclusion Criteria: * Study participant is considered to be medically healthy, based on a clinical evaluation including medical history, physical examinations, clinical laboratory tests, vital sign measurements, and a 12-lead electrocardiogram performed at the screening visit. Specifically, stu...
Erythromycin is a small molecule being studied in healthy volunteers. It is being evaluated in a Phase 1 clinical trial to assess its effects on the pharmacokinetics of relugolix, estradiol, and norethindrone in healthy postmenopausal women, and on the pharmacokinetics of relugolix in healthy adult men.
Erythromycin is a macrolide antibiotic that targets bacterial protein synthesis. In the context of the Phase 1 trial, it is used as a potential inhibitor of drug-metabolizing enzymes to study its interaction with relugolix, estradiol, and norethindrone.
Erythromycin is being developed by Roivant Sciences Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker ROIV. The company is conducting a Phase 1 clinical trial to evaluate the drug's effects on the pharmacokinetics of other medications in healthy subjects.
Erythromycin is in Phase 1 clinical development. The Phase 1 trial, NCT04714554, has been completed. The study enrolled 43 participants and was conducted in the United States. Erythromycin is an investigational drug in this context and is not approved for this use.
Erythromycin is associated with one completed Phase 1 clinical trial, NCT04714554. The trial studied the effects of erythromycin on the pharmacokinetics of relugolix, estradiol, and norethindrone in healthy postmenopausal women, and on relugolix in healthy adult men. It enrolled 43 participants in the United States.
Erythromycin is a well-known macrolide antibiotic, but in this clinical trial context, it is being studied as a pharmacokinetic probe. No alternative names for this specific use are provided. The trial focuses on its interaction with relugolix, estradiol, and norethindrone.