The phase 1 portion of this study is an open-label, multicenter, dose-escalation study of 1-month depot TAK-448 in adult males with prostate cancer who are either on gonadotropin releasing hormone (GnRH) therapy or who might be eligible for GnRH therapy in the future. The phase 2 portion of this study is an open-label, multicenter, randomized study in men with prostate cancer that will confirm the testosterone- and prostate specific antigen (PSA)- lowering potential of up to 2 dose levels of 1-month depot TAK-448.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Phase 2 portion of study: patients randomized to this arm will receive a subcutaneous injection of depot Leuprorelin in the abdomen once per month for up to 6 months
Phase 1 portion of study: Patients will be administered a single dose of depot formulation TAK-448 via subcutaneous abdominal injection and a single dose of placebo at a contralateral injection site Phase 2 portion of the study: Patients randomized to this arm will be administered depot formulation TAK-448 (up to 2 dose levels) via subcutaneous injection in the abdomen once per month for up to 6 months
Hôpital Edouard Herriot, 5, Place d'Arsonval, Pavillon V - Urologie et chirurgie de la transplantation
Lyon, France
For Phase 1 portion of study: to assess the safety and pharmacokinetics (PK) of TAK-448 in patients receiving a single dose of 1-month depot TAK-448
Vital signs; 12-lead ECG; Clinical laboratory test results; Injection site-related skin reactions; Adverse Events (AEs)and Serious Adverse Events (SAEs); Maximum observed plasma concentration; Area under the plasma TAK-448 disposition curve; The time of last quantifiable concentration
Time frame: 3 months
For Phase 2 portion of study: to assess the safety and PK of TAK-448 and effect of TAK-448 on serum testosterone concentrations in patients receiving repeated doses of 1-month depot TAK-448
Vital signs; 12-lead ECG; Clinical laboratory test results; Injection site-related skin reactions; Adverse Events (AEs)and Serious Adverse Events (SAEs; Area under the plasma TAK-448 disposition curve; trough plasma concentration; Serum testosterone concentration; proportion of patients with serum concentration below castrate level
Time frame: 8 months
For Phase 1 portion of study: to assess the effect of 1-month depot TAK-448 on serum testosterone and luteinizing hormone (LH) concentrations in patients not receiving concomitant gonadotropin releasing hormone (GnRH) analog therapy
Serum testosterone and LH concentrations; proportions of patients with serum testosterone concentrations below castrate-level
Time frame: 3 months
For Phase 2 portion of study: to assess the effect of 1-month depot TAK-448 on serum prostate specific antigen (PSA) concentration
Serum PSA concentration
Time frame: 8 months
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