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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Participants will receive Test follitropin alfa in Period 1 followed by Reference follitropin alfa in Period 2. |
|
| Sequence 2 | Experimental | Participants will receive reference follitropin alfa in Period 1 followed by test follitropin alfa in Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test: Follitropin alfa | Combination Product | 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. |
| Measure | Description | 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 |
| Measure | Description | 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 | |
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Inclusion Criteria:
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:
History of clinically relevant cardiovascular events
History of tumors of the pituitary gland or hypothalamus
Smokers
Other protocol defined exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | EMD Serono Research & Development Institute, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Early Phase Services, LLC_Clinic San Antonio | San Antonio | Texas | 78209 | United States |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| US Medical Information website, Medical Resources | View source |
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We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
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| Reference: Follitropin alfa | Drug | 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. |
|
| Zoladex | Drug | 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. |
|
| 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) |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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