Effects of TAK-448 in Middle-aged and Older Men With Low Testosterone

NCT ID: NCT02381288

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-10
• Study Completion Date: 2016-04-08

Brief Summary

The purpose of this study is to evaluate the effects on serum testosterone (ST) after 6 weeks of subcutaneous (SC) administration of different doses and dosing frequencies of TAK-448 to middle-aged and older men with low ST levels.

Detailed Description

The drug tested in this study is called TAK-448. TAK-448 was tested to define a dose and dose frequency which results in a clinically relevant improvement in ST in middle-aged and older men with low ST levels. This study looked at ST levels in men who took TAK-448.

The study enrolled 17 participants. Participants were randomly assigned (by chance, like flipping a coin) to one of the following treatment groups-which remained undisclosed to the participants and study doctor during the study (unless there is an urgent medical need):

• TAK-448 0.1 µg
• TAK-448 0.3 µg
• TAK-448 1.0 µg
• Placebo (dummy inactive injection) - this was a injection that looks like the study drug but has no active ingredient All participants received subcutaneous injection either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.

This single-center trial was conducted in the United States. The overall time to participate in this study is up to 56 days. Participants made daily visits to the clinic for 8 weeks, and were contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

Conditions

Low Testosterone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TAK-448 0.1 mcg

TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42.

Group Type: EXPERIMENTAL

TAK-448

Intervention Type: DRUG

TAK-448 solution for subcutaneous injection

TAK-448 0.3 mcg

TAK-448 0.3 mcg, injection, subcutaneously, twice-weekly on Days 1 through 39.

Group Type: EXPERIMENTAL

TAK-448

Intervention Type: DRUG

TAK-448 solution for subcutaneous injection

TAK-448 1.0 mcg

TAK-448 1.0 mcg, injection, subcutaneously, once-weekly on Days 1 through 36.

Group Type: EXPERIMENTAL

TAK-448

Intervention Type: DRUG

TAK-448 solution for subcutaneous injection

Placebo

TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.

Group Type: PLACEBO_COMPARATOR

TAK-448

Intervention Type: DRUG

TAK-448 solution for subcutaneous injection

TAK-448 Placebo

Intervention Type: DRUG

TAK-448 placebo-matching solution for subcutaneous injection

Interventions

TAK-448

TAK-448 solution for subcutaneous injection

Intervention Type: DRUG

TAK-448 Placebo

TAK-448 placebo-matching solution for subcutaneous injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Has total serum testosterone (ST) levels less than 300 ng/dL at Screening.

2. Has a body mass index (BMI) between 20.0 and 40.0 kg/m^2, inclusive at Screening.

3. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from the time of signing of informed consent throughout the duration of the study and for 12 weeks after the last dose.

Exclusion Criteria

1. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality that may impact the ability of the participant to participate or potentially confound the study results. Participants will be excluded based on:

1. Has a serum creatinine >2.0 milligrams per deciliter (mg/dL) at Screening.

2. Is receiving dialysis treatment.

3. Has an American Urological Association (AUA)/ International Prostate Symptom Score (I-PSS) score of >19 or serum prostate-specific antigen (PSA) >4 nanogram per milliliter (ng/mL) at Screening.

4. Has thyrotropin (TSH) levels less than (<) 0.3 or >7.5 milli-international units per liter (mIU/L) at Screening.

5. Has systolic blood pressure >160 millimeter of mercury (mm Hg) or diastolic blood pressure >100 mm Hg (if out of range may be repeated once for eligibility determination) at Screening.

6. Has luteinizing hormone (LH) >9.4 units per liter (U/L) at Screening.

7. Is receiving insulin therapy.

8. Has a hematocrit <30 percent (%) or >48% at Screening.

9. Has a glycosylated hemoglobin (HbA1c) >8.0 at Screening (Cohort 1).

2. Has type 2 diabetes mellitus defined as fasting blood glucose >125 mg/dL, glycosylated hemoglobin (HbA1c) >6.2%, or use of antidiabetic medication (Cohort 2 only).

3. Has clinical evidence of anatomic or pathological hypothalamic/pituitary/testicular disease, such as (but not limited to) Klinefelter's syndrome, Kallmann's syndrome, systemic infiltrative diseases (hemochromatosis, sarcoidosis, Wilson's disease), or prior pituitary surgery.

4. Has used gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists, antiandrogens, clomiphene, or other reproductive hormone-related agents within 6 months prior to Screening.

5. Has used anabolic therapies (testosterone, dehydroepiandrosterone [DHEA], androstendione, any other androgen, or recombinant human growth hormone) within 1 year of Screening.

• Minimum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director Clinical Science

Role: STUDY_DIRECTOR

Takeda

Locations

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

U1111-1150-2776

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-448-2002

Identifier Type: -

Identifier Source: org_study_id