NIPH Clinical Trials Search

Domestic Phase I clinical study to evaluate the pharmacokinetics and safety of NMK02 in Japanese patients with prostate cancer

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Prostate Cancer
Date of first enrollment	22/06/2026
Target sample size	10
Countries of recruitment
Study type	Interventional
Intervention(s)	NMK02 will be administered as a single dose of 333 +/- 37 MBq via intravenous bolus injection.

Outcome(s)

Primary Outcome

Time course changes in radioactivity concentration in blood and plasma (per unit volume), radioactivity kinetic parameters based on radioactivity concentration in blood and plasma (AUCinf, AUClast, Cmax, Tmax, T1/2 alpha, T1/2 beta, CL, Vss, mean residence time [MRT], plasma/blood ratio), cumulative urinary radioactivity excretion rate up to each urine collection time point, urinary radioactivity kinetic parameters based on urinary radioactivity excretion rate at each urine collection time point (Tmax, Rate max, Rate last, T1/2 elim).

Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Male
Include criteria	All of the following inclusion criteria must be met: 1. Male participants who are ethnically Japanese, defined as having both biological parents of Japanese origin and born in Japan. 2. Participant is >= 18 years of age at the time of consent. 3. Participant has provided signed informed consent and confirms that he is able and willing to comply with all protocol requirements. 4. Histologically confirmed adenocarcinoma of the prostate. 5. At least high-risk prostate cancer as defined by NCCN Guidelines Version 4.2026 (Clinical stage >=T3, or PSA >20 ng/mL, or Gleason score >=8).
Exclude criteria	Participants meeting any of the following exclusion criteria are not eligible for this study: 1. Participant has taken part in another clinical trial within 30 days prior to obtaining consent or is scheduled to participate in another clinical trial during the period from the investigational drug administration day to 7 days after administration (Day 1 to Day 8). 2. Participant is known to have hypersensitivity to the investigational drug, its excipients, or components of drugs in the same class. 3. Participants with clinically significant renal or hepatic impairment, defined as an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, total bilirubin > 3 times the upper limit of normal (ULN), or aspartate transaminase/alanine transaminase > 5 times the ULN. 4. Participant has, in the judgment of the investigator, diseases or other conditions that may interfere with obtaining reliable data, achieving the study objectives, or completing the study. 5. Participant has received androgen deprivation therapy, neoadjuvant therapy with investigational drugs, or any intervention for prostate cancer within 2 weeks prior to obtaining consent.