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A Study to Assess the Safety, Pharmacological Effect and Plasma Concentration of ASP7991 After Single Oral Administration to Healthy Volunteers

NCT ID: NCT01675518

Last Updated: 2012-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-06-30

Brief Summary

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This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after single oral administration to healthy volunteers. In part-1, ASP7991 is administered in a dose escalation design. In part-2, plasma concentration changes of ASP7991 in fasted and fed conditions are compared.

Detailed Description

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This study consists of two parts. In Part 1, the study will begin as a single rising dose escalation design under randomized double-blind and fasting conditions. In each dose group, volunteers will be randomized to receive an oral administration of either active drug (ASP7991) or placebo. The dose escalation will be determined after blinded safety assessment.

Part 2 is a study to evaluate the effect of food intake. ASP7991 will be administered to volunteers under 2 conditions, fasting and fed, on 2-way crossover method.

Conditions

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Healthy Pharmacokinetics of ASP7991

Keywords

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Plasma concentration ASP7991 food effect PTH (parathyroid hormone)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part-1 dose 1

Group Type EXPERIMENTAL

ASP7991

Intervention Type DRUG

oral

Part-1 dose 2

Group Type EXPERIMENTAL

ASP7991

Intervention Type DRUG

oral

Part-1 dose 3

Group Type EXPERIMENTAL

ASP7991

Intervention Type DRUG

oral

Part-1 dose 4

Group Type EXPERIMENTAL

ASP7991

Intervention Type DRUG

oral

Part-1 dose 5

Group Type EXPERIMENTAL

ASP7991

Intervention Type DRUG

oral

Part-1 dose 6

Group Type EXPERIMENTAL

ASP7991

Intervention Type DRUG

oral

Part-1 placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral

Part-2 fed

Group Type EXPERIMENTAL

ASP7991

Intervention Type DRUG

oral

Part-2 fasted

Group Type EXPERIMENTAL

ASP7991

Intervention Type DRUG

oral

Interventions

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ASP7991

oral

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy, as judged by the investigator/sub investigator based on the results of physical examination obtained before study drug administration
* Body weight: ≥50.0 kg, \<80.0 kg
* BMI: ≥17.6, \<26.4
* Serum corrected calcium concentration: ≥9.0mg/dL, \<10.4 mg/dL

Exclusion Criteria

* Received any investigational drugs in other clinical or post-marketing studies within 120 days before screening
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before screening
* Received medication (including marketed drug) within 7 days before hospitalization, vitamin preparation including vitamin D and supplement including calcium or is scheduled to receive medication
* A deviation from normal criteria range of 12-lead ECG (QT evaluation)
* A deviation from the normal range in clinical laboratory tests
* Highly sensitive cardiac troponin T (at screening): ≥0.014 ng/mL
* History of drug allergies
* Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before admission
* Concurrent or previous hepatic disease (e.g., viral hepatitis, drug-induced liver injury)
* Concurrent or previous endocrine disorders (e.g.,hyperthyroidism, aberration in growth hormone)
Minimum Eligible Age

20 Years

Maximum Eligible Age

44 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

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Kantou, , Japan

Site Status

Countries

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Japan

Other Identifiers

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7991-CL-0001

Identifier Type: -

Identifier Source: org_study_id