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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
17
TAK-448 solution for subcutaneous injection
TAK-448 placebo-matching solution for subcutaneous injection
Unnamed facility
Boston, Massachusetts, United States
Percent Change From Baseline in Average Serum Concentration (Cav) of Total ST After 6 Weeks of Dosing
Cav is the average serum concentration of the dosing interval, calculated as area under the effect curve (AUEC) divided by the duration of the dosing interval.
Time frame: Once-daily regimen Day 42; Twice-weekly regimen Day 39; Once-weekly regimen Day 36
Trough Serum Concentration (Ctrough) of ST
Trough serum concentration of total and free ST, defined as lowest Baseline concentration.
Time frame: Once-daily regimen Day 42; Twice-weekly regimen Day 39; Once-weekly regimen Day 36
Serum Testosterone Cmax: Maximum Observed Plasma Concentration
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Assessments were done Day 1 and Day 42 for once daily regimen, on Day 36 for once weekly regimen and on Day 39 for twice-weekly regimen (Day 42/36/39).
Time frame: Day 1 (first dose) and Day 42 for once-daily regimen, Day 39 for twice-weekly regimen, or Day 36 for once-weekly regimen (last dose)
Cmax: Maximum Observed Plasma Concentration for the Free Form of TAK-448 (TAK-448F)
Cmax is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time frame: Once-daily Dosing Days 1 and 42, Twice-weekly Dosing Days 1 and 39, Once-weekly Dosing Days 1 and 36, predose and at multiple time intervals (up to 8 hours) post-dose.
AUCt: Area Under the Plasma Concentration-Time Curve for TAK-448F
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.
Time frame: Once-daily Dosing Days 1 and 42, Twice-weekly Dosing Days 1 and 39, Once-weekly Dosing Days 1 and 36, predose and at multiple time intervals (up to 8 hours) post-dose.
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Terminal Elimination Half-life (T1/2) for TAK-448F
T1/2 is the time required for half of the drug to be eliminated from the plasma.
Time frame: Once-daily Dosing Days 1 and 42, Twice-weekly Dosing Days 1 and 39, Once-weekly Dosing Days 1 and 36, predose and at multiple time intervals (up to 8 hours) post-dose.