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

Healthy Clinical Trial

Official title:

A Phase 1 Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Oral Administration of ASP7991 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675518
• Other study ID #: 7991-CL-0001
• Status: Completed
• Phase: Phase 1
• First received: August 28, 2012
• Last updated: August 28, 2012
• Start date: January 2012
• Est. completion date: June 2012

Study information

• Verified date: August 2012
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 44 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy
• Pharmacokinetics of ASP7991

Intervention

Drug:
• ASP7991
oral
• Placebo
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs and Holter ECGs		for 96 hours after dosing	No
Secondary	Plasma Concentration of unchanged drug :Cmax, tmax, AUClast, AUCinf, t1/2, CL/F	Blood samples are collected at the following times: redose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12,16, 24, 48, 72 and 96 hours	for 96 hours after dosing	No
Secondary	Urinary concentrations of unchanged drug: Aelast,Aelast%, CLr	Urine samples are collected at the following times: redose and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours	for 96 hour after dosing	No
Secondary	plasma parathyroid hormon concentration	Blood samples are collected at the following times: redose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12,16, 24, 48, 72 and 96 hours	for 96 hours after dosing	No