Current partner codePEPTIDESDE
NCT01279915·Phase 1·INTERVENTIONAL

A Safety and Pharmacokinetics Study of ASP0456 in Healthy Subjects

Status

Completed

Phase

Phase 1

Enrollment

32

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending dose of ASP0456 in non-elderly healthy subjects.

Interventions

Treatment arms and agents.

DRUG

ASP0456

oral

DRUG

Placebo

oral

Timeline

From registration to results.

  1. First posted

    Jan 20, 2011

  2. Study start

    Oct 2010

  3. Primary completion

    Jan 2011

  4. Study completion

    Jan 2011

  5. Results posted

    Not reported

  6. Registry updated

    Jan 20, 2011

Outcomes

What the study measures.

Primary outcomes

Pharmacokinetics of ASP0456 assessed by its plasma concentration change

Time frame · For 48 hours after dosing

Secondary outcomes

Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and labo tests

Time frame · For 48 hours after dosing

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
44 Years
Sex
MALE
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); ≥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

Study locations

1 registered sites.

Japan. Showing up to 24 locations stored in the fast local snapshot.

Facility not named

Kantou, Japan

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.