A Phase 1, Open-Label, Randomized, Three-Period, Crossover Study to Evaluate the Relative Bioavailability of Naldemedine Granule to Tablet and the Effect of Food on the Pharmacokinetics of Naldemedine

A Phase 1, Open-Label, Randomized, Three-Period, Crossover Study to Evaluate the Relative Bioavailability of Naldemedine Granule to Tablet and the Effect of Food on the Pharmacokinetics of Naldemedine in Healthy Adult Subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224678

Enrollment

Registered

2019-05-13

Start date

2019-04-23

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 Caucasian adult subjects

Interventions

investigational material(s) Generic name etc : naldemedine INN of investigational material : naldemedine Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy Caucasian adult subjects between the ages >=20 and <=55

Exclusion criteria

Exclusion criteria: Subjects who are considered by the investigator or subinvestigator to be unsuitable for participation in the study for any reason. etc.

Design outcomes

Primary

Measure	Time frame
pharmacokinetics maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last), area under the concentration-time curve extrapolated from time zero to infinity (AUC0-inf), terminal elimination rate constant (lambdaz) , terminal elimination half-life (t1/2,z), mean residence time (MRT), and apparent total clearance (CL/F).	—

Measure

Time frame

pharmacokinetics maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last), area under the concentration-time curve extrapolated from time zero to infinity (AUC0-inf), terminal elimination rate constant (lambdaz) , terminal elimination half-life (t1/2,z), mean residence time (MRT), and apparent total clearance (CL/F).

—

Secondary

Measure	Time frame
safety Vital signs, electrocardiograms, clinical laboratory tests, and adverse events (AEs).	—

Countries

Japan

Outcome results

None listed

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