Hypogonadism
Conditions
Keywords
Male Infertility, Follicle Stimulating Hormone
Brief summary
The purpose of this study is to assess the bioequivalence of Test and Reference in healthy downregulated male participants. This is a 2-sequence, 2-period study using the following treatment sequences across Study Periods 1 and 2. At the end of the first Downregulation period (DR1), eligible participants will be randomly assigned to 1 of the 2 treatment sequences: Sequence 1: Test - Reference Sequence 2: Reference - Test Where, Test = follitropin alfa (solution for injection in prefilled pen), and Reference = follitropin alfa (powder and diluent for solution for injection in vial). The total duration of the study will be up to approximately 9 weeks.
Interventions
COMBINATION_PRODUCTTest: Follitropin alfa
It is a solution for injection in prefilled pen. Participants will receive follitropin alfa on Day 1 in Study Period 1 or Study Period 2. A washout period of at least 23 days will be maintained between period 1 and 2.
DRUGReference: Follitropin alfa
It is a powder and diluent for solution for injection in multidose vial. Participants will receive follitropin alfa on Day 1 in Study Period 1 or Study Period 2. A washout period of 23 days will be maintained between period 1 and 2.
DRUGZoladex
It is a auxiliary medicinal product. Participants will receive Zoladex injection on Day -11 in down regulation period, and on Day 17 prior to the start of Period 2.
Sponsors
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy, as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring * Have a normal baseline testosterone level * Have a body weight of more than equal to 60 kilograms and Body Mass Index within the range 18 to 30 kilograms per meter square * Other protocol defined inclusion criteria could apply
Exclusion criteria
* Any condition, that, in the Investigator's opinion, constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation. * Participants using the following within 28 days prior to start of study intervention: * Drugs or herbal formulations known to increase testosterone levels (e.g. topical testosterone, sildenafil, fluoxymesterone, herbal remedies containing ginseng) * Medicinal products known to prolong the QTc interval or medicinal products able to induce torsades de pointes (e.g. antiarrhythmic, antipsychotics, antidepressants, macrolide and quinine antimicrobials, azole antifungals). * History of clinically relevant cardiovascular events * History of tumors of the pituitary gland or hypothalamus * Smokers * Other protocol defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline Adjusted Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Sampling Time After Administration (AUC0-t, adj) of Follitropin Alfa | Predose at -45, - 30, -15 minutes, and at 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, (Day 1), 24 and 36 hour (h) (Day 2), 48 h (Day 3), 72 h (Day 4), 96 h (Day 5), 120 h (Day 6), 168 h (Day 8) and 216h (Day 10) after Test/Reference administration |
| Baseline Adjusted Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-inf,adj) of Follitropin Alfa | Predose at -45, - 30, -15 minutes, and at 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, (Day 1), 24 and 36 hour (h) (Day 2), 48 h (Day 3), 72 h (Day 4), 96 h (Day 5), 120 h (Day 6), 168 h (Day 8) and 216h(Day 10) after Test/Reference administration |
| Baseline Adjusted Maximum Observed Serum Concentration (Cmax,adj) of Follitropin Alfa | Predose at -45, - 30, -15 minutes, and at 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, (Day 1), 24 and 36 hour (h) (Day 2), 48 h (Day 3), 72 h (Day 4), 96 h (Day 5), 120 h (Day 6), 168 h (Day 8) and 216h(Day 10) after Test/Reference administration |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | Up to Day 37 |
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by Severity | Up to Day 37 |
| Occurrence of Abnormalities (Grade >=3) in Laboratory Test Values | Up to Day 37 |
| Occurrence of Abnormalities (Grade >=3) in Vital Signs | Up to Day 37 |
| Occurrence of Clinically Significantly Abnormal Electrocardiograms (ECGs) | Up to Day 37 |
| Number of Participants With Local Tolerability/Injection Site Reactions (ISRs) | Up to Day 37 |
| Pharmacokinetic (PK) Plasma Concentrations of Follitropin Alfa | Predose at -45, - 30, -15 minutes, and at 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, (Day 1), 24 and 36 hour (h) (Day 2), 48 h (Day 3), 72 h (Day 4), 96 h (Day 5), 120 h (Day 6), 168 h (Day 8) and 216h(Day 10) after Test/Reference administration |
| Number of Participants With Positive Anti-Drug Antibody (ADA) of Follitropin Alfa | Predose: Day 1 (Period 1), Day 28 (Period 2), Day 37 (End of Treatment). ADA positive participants followed until end of study(earliest of ADA negative(baseline) or loss to follow-up (upto 40 months) |
Countries
United States
Contacts
STUDY_DIRECTORMedical Responsible
EMD Serono Research & Development Institute, Inc.
Outcome results
None listed