Open-label study to assess safety, pharmacokinetics and exposed dose of NMK20 in healthy Japanese male subjects

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222333

Enrollment

Registered

2013-12-19

Start date

2013-12-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Japanese male subjects

Interventions

investigational material(s) Generic name etc : NMK20 INN of investigational material : - Therapeutic category code : 43- Radioactive medicines Dosage and Administration for Investigational material :

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: -Body weight: 50.0 kg or more -Body mass index: 18.5 and more - 25.0 below

Exclusion criteria

Exclusion criteria: -Subjects with abnormality found by liver function test or renal function test. -Subjects with a hypersensitive history to drugs or foods. -Subjects who have abused or are abusing drugs. -Subjects who were or are addicted to alcohol. -Subjects who have received an investigational new drug other than NMK20 from six months before screening up to hospital admission. etc.

Design outcomes

Primary

Measure	Time frame
Safety Assessment of subjective/objective symptoms, electrocardiogram exams, vital signs, clinical tests	—

Secondary

Measure	Time frame
Pharmacokinetics and exposed dose Pharmacokinetics: 1) Assessment of radioactivity in blood, radioactivity distribution rate in organs/tissue and urinary excretion rate of radioactivity 2) Assessment of unchanged drug and radioactive metabolites in blood plasma and urine Exposed dose: Calculation of exposed dose by medical internal radiation dose(MIRD) method	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026