A Study to Evaluate Safety of Multiple Dose of ASP0456 in Healthy Subjects

Phase I Study of ASP0456 - A Double-blind, Placebo-controlled, Multiple Ascending Dose Study / Investigational Study for Dose Timing Selection in Non Elderly Healthy Subjects-

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01427387

Enrollment

Registered

2011-09-01

Start date

2011-06-30

Completion date

2011-09-30

Last updated

2011-09-23

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

Conditions

Healthy, Pharmacokinetics of ASP0456

Keywords

ASP0456, Pharmacokinetics, safety, tolerability, food effect

Brief summary

A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending dose of ASP0456 in non-elderly healthy subjects. Two dosing condition, pre-prandial and postprandial administrations, is compared.

Interventions

DRUGASP0456

oral

DRUGPlacebo

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 44 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy, as judged by the investigator/subinvestigator based on the results of physical examination and all tests obtained * Body weight (at screening); * female ≥40.0 kg,\<70.0 kg * male ≥50.0 kg,\<80.0 kg * BMI(at screening): ≥17.6,\<26.4

Exclusion criteria

* Received any investigational drugs in other clinical or post-marketing studies within 120 days before the study * Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study * Received medication within 10 days before dose is administered or is scheduled to receive medication * History of drug allergies * Upper (e.g. nausea, vomiting, stomachache) and lower (e.g. abdominal pain) gastrointestinal disease within 7 days before the study * Concurrent or previous hepatic disease * Concurrent or previous heart disease * Concurrent or previous renal disease

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics (such as Cmax, AUC and t1/2 etc.) of ASP0456 assessed by its plasma concentration change	For 48 hours after dosing

Secondary

Measure	Time frame
Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and labo tests	For 48 hours after dosing

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026