Correcting low testosterone levels in men with diabetes: A new treatment approach

Phase 1

• Conditions: Hypogonadotropic Hypogonadism; MedDRA version: 18.1Level: LLTClassification code 10021012Term: Hypogonadotrophic hypogonadismSystem Organ Class: 100000004860; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2014-002155-25-GB
• Lead Sponsor: Takeda Development Centre Europe Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-18
• Last Update Posted: 31 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

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 <12% at Screening and is on a stable dose of diabetes therapies (including insulin and/or glucagon-like peptide-1 therapies).
7.The subject has a LH concentration <8 IU/L at Screening.
8.A male subject who is nonsterilized* and sexually active with a female partner of childbearing potential* agrees to use adequate contraception* from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
*Definitions and acceptable methods of contraception are defined in Section 9.1.10 Contraception and Pregnancy Avoidance Procedure and reporting responsibilities are defined in Section 9.1.11 Pregnancy of the protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified