A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male Participants

Merck KGaA (EMD Serono)

Status and phase: Enrolling; Phase 1

Conditions: Hypogonadism

Treatments: Drug: Zoladex; Drug: Reference: Follitropin alfa; Combination Product: Test: Follitropin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT07097259

MS700623_0617

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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 exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Sequence 1

Experimental group

Description:

Participants will receive Test follitropin alfa in Period 1 followed by Reference follitropin alfa in Period 2.

Treatment:

Combination Product: Test: Follitropin alfa

Drug: Reference: Follitropin alfa

Drug: Zoladex

Sequence 2

Experimental group

Description:

Participants will receive reference follitropin alfa in Period 1 followed by test follitropin alfa in Period 2.

Treatment:

Combination Product: Test: Follitropin alfa

Drug: Reference: Follitropin alfa

Drug: Zoladex