Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04714554
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2021-01-08
Brief Title:
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
Sponsor:
Myovant Sciences GmbH
Organization:
Myovant Sciences GmbH
Study Overview
Official Title:
A Two-Part Open-Label Fixed-Sequence Two-Period Crossover Study to Assess the Effects of Erythromycin on the Pharmacokinetics of Relugolix Estradiol and Norethindrone After Administration of the RelugolixEstradiolNorethindrone Acetate Fixed-Dose Combination Tablet in Healthy Postmenopausal Women and on the Pharmacokinetics of Relugolix After Administration of a Single 120-mg Dose in Healthy Adult Men
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Each study part consists of two sequential treatment periods Treatment Period 1 and Treatment Period 2 in which study participants will receive study treatments in a fixed single-sequence crossover manner In Part 1 of the study a single relugolixE2norethindrone acetate NETA 40 milligrams mg1 mg05 mg fixed-dose combination FDC tablet will be administered alone on Day 1 of Treatment Period 1 in Treatment Period 2 erythromycin will be administered on Day 1 to Day 12 500 mg four times daily QID with co-administration of a single FDC tablet with the morning dose of erythromycin on Day 8 In Part 2 of the study a single 120-mg dose of relugolix will be administered alone on Day 1 of Treatment Period 1 in Treatment Period 2 erythromycin will be administered on Day 1 to Day 12 500 mg QID with co-administration of a single 120-mg dose of relugolix with the morning dose of erythromycin on Day 8 There will be a nine-day washout interval between administration of study drug the FDC tablet Part 1 or relugolix 120 mg Part 2 on Day 1 of Treatment Period 1 and Treatment Period 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None