Hypogonadotropic Hypogonadism MedDRA version: 18.1 Level: LLT Classification code 10021012 Term: Hypogonadotrophic hypogonadism System Organ Class: 100000004860
Conditions
Interventions
Product Name: TAK-448 0.2 mg/2 mL
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not Yet Known
Current Sponsor code: TAK-448
Other descriptive name: Peptide analog of kisspeptin
Co
Sponsors
Takeda Development Centre Europe Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements. 2.The subject or, when applicable, the subject’s legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 3.The subject has two morning total ST concentrations of =12.0 nmol/L ( =3.46 ng/mL) taken during the Screening period. 4.The subject is male and aged 18 to 60 years, inclusive. 5.The subject has a body mass index (BMI) between 25.0 and 50.0 kg/m2, inclusive. 6. If diagnosed with T2DM, the subject has a HbA1c concentration =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.The subject has received any investigational compound within 30 days prior to Screening. 2.The subject has received TAK-448 in a previous clinical study, or previous cohort. 3.The subject is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress. 4.The subject has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality (other than T2DM, its complications and associated conditions), which may impact the ability of the subject to participate or potentially confound the study results. 5.The subject has a recent history or clinical manifestations of significant CVD – such as a history of myocardial infarction or stroke in the 6 months preceding the Screening visit or has untreated peripheral arterial disease. 6.The subject has a history of hypersensitivity or allergies to any component of the formulation of TAK-448. 7.The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 5 years prior to Screening. 8.The subject is required to take excluded medications, supplements, or food products listed in Section 7.3. 9.The subject intends to donate sperm during the course of this study or for 12 weeks after the last dose of study drug. 10.The subject has clinical evidence of anatomic or pathological hypothalamic/pituitary disease. 11.There is any finding in the subject’s medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking TAK-448, or a similar drug in the same class that might interfere with the conduct of the study. 12.The subject has a history of cancer (including prostate cancer), with the exception of basal cell carcinoma which has been in remission for at least 5 years prior to Screening. 13.The subject has a history of or present symptomatic prostate disease (including benign prostatic hyperplasia) or PSA is >4 ng/mL at Screening. 14.The subject has a known history of human immunodeficiency virus infection at Screening. 15.The subject is deemed by the study team to have poor peripheral venous access. 16.The subject has donated or lost 450 mL or more of his blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days prior to Screening, or is planning to donate blood for 12 weeks after the last dose of study medication. 17.The subject has a Screening or Day -1 abnormal (clinically significant) ECG. Entry of any subject with an abnormal (not clinically significant) ECG must be approved, and documented by signature of the principal investigator or medically qualified subinvestigator. 18.The subject has abnormal Screening or Day -1 laboratory values that suggest a clinically significant underlying disease or subject with the following lab abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2× the upper limits of normal (ULN). 19.The subject, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason. 20.The subject has had more than two severe hypoglycemic events (requiring third party assistance) within 6 months prior to the Screening Visit. 21.The subject has a diagnosis of type 1 diabetes me
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): •Percent change from Baseline in area under the effect curve from time 0 to 72 hours (AUEC72) of total ST after 4 weeks of SC dosing with TAK-448 (Day 25 for twice-weekly dosing, Day 22 for once-weekly dosing). •Percent change from Baseline in AUEC72 of free ST after 4 weeks of SC dosing with TAK 448 (Day 25 for twice-weekly dosing, Day 22 for once-weekly dosing). •Trough serum concentration (Ctrough defined as lowest Baseline compared to predose of the last dose) of total ST after 4 weeks of SC dosing. •Ctrough (lowest Baseline compared to predose of the last dose) of free ST after 4 weeks of SC dosing. ;Timepoint(s) of evaluation of this end point: 4 weeks (Day 22 for once - week dosing and or Day 25 for twice-week dosing);Main Objective: To evaluate the effects on Serum Testosterone(ST) after 4 weeks of SC dose administration, with different doses and dosing frequencies of TAK-448 to overweight/obese subjects with Hypogonadotropic Hypogonadism.;Secondary Objective: To evaluate pharmacokinetics (PK) of TAK-448 free base form (TAK-448F) after a single SC dose and after 4 weeks of repeated SC dose administration with different doses and dosing frequencies of TAK-448. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Cmax of TAK-448F after first dose (Day 1) and after final dose. •Area under the plasma concentration time curve of TAK-448F from time 0 to infinity (AUC8) after first dose (Day 1) and after final dose. •Area under the plasma concentration-time curve of TAK-448F from time 0 to time of the last quantifiable concentration (AUCt) after first dose (Day 1) and after 4 weeks of dosing. •Terminal elimination half life (t1/2z) of TAK-448F after single (Day 1) and multiple dose (after 4 weeks of dosing). ;Timepoint(s) of evaluation of this end point: After first dose (Day 1) and after 4 weeks of dosing (final dose) | — |
Countries
United Kingdom
Contacts
Public ContactRudi Taljaard
Takeda Development Centre Europe Ltd
Outcome results
None listed