Multiple Oral Administration of ASP7991 to Non-elderly Male Subjects

Healthy Clinical Trial

Official title:

Randomized, Double-blinded, Placebo-controlled, Multiple Oral Administration of ASP7991 to Non-elderly Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872013
• Other study ID #: 7991-CL-1002
• Status: Completed
• Phase: Phase 1
• First received: June 5, 2013
• Last updated: June 5, 2013
• Start date: November 2012
• Est. completion date: February 2013

Study information

• Verified date: June 2013
• 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 multiple oral administrations to non-elderly subjects.

Description:

In each step (lowest dose, middle dose, highest dose), subjects are randomly assigned in a double blinded manner to receive either ASP7991 (n=9) or Placebo (n=3) and are administered repeatedly. Once daily, the subjects are administered ASP7991 or placebo orally 30 minutes after breakfast with 150 mL water for 7 days. After the each step the sponsor evaluates the safety in the blinded manner for deciding an escalation to the step.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 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: Safety 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, ECGs for QT evaluation and slit lamp examination		For 96 hours after dosing	Yes
Secondary	Plasma concentrations unchanged drug; AUC24h, Cmax, Ctrough, tmax, t1/2, CL/F, Vz/F		For 96 hours after dosing	No
Secondary	Urinary concentrations unchanged drug; Aelast, Aelast%, CLR		For 96 hours after dosing	No