A Clinical Trial to Investigate Safety and Tolerability of ASP7962 in Healthy Humans

NCT ID: NCT01981928

Last Updated: 2014-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-05-31

Brief Summary

The purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is taken up, metabolized (chemically broken down), distributed through the body and excreted. A further aim is to look at how this process is possibly altered by food by giving the study drug in the presence and absence of meals.

Conditions

Safety; Tolerability; Pharmacokinetics of ASP7962

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

ASP7962

Each dose level group will include 8 subjects, of which 6 will be randomized to receive active ASP7962

Group Type: EXPERIMENTAL

ASP7962

Intervention Type: DRUG

Oral

Placebo

Each dose level group will include 8 subjects, of which 2 will be randomized to receive placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral

Interventions

ASP7962

Oral

Intervention Type: DRUG

Placebo

Oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The subject has a body mass index (BMI) range of 18.5 - 30.0 kg/m2, inclusive. The subject weighs at least 50 kg. [screening]
• Female subject must be of non-childbearing potential:postmenopausal (defined as at least 1 year without any menses) prior to screening, or documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening).
• Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and continue throughout the clinical study period and for 90 days after the final study drug administration.
• Male subject must not donate sperm starting at screening and throughout the clinical study period and for 90 days after the final study drug administration.
• Subject agrees not to participate in another interventional study while in this clinical study.

Exclusion Criteria

• Subject has a known or suspected hypersensitivity to ASP7962 or any components of the formulation used.Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy, as judged by the Medical Investigator.
• Subject has any clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests at screening or on admission to the clinical unit on day -1.
• Subject regularly uses any inducer of metabolism (e.g., barbiturates, rifampin) in the 3 months prior to admission to the clinical unit on day -1.
• Subject had any significant blood loss, donated 1 unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to admission to the clinical unit on day -1.
• Subject participated in any interventional clinical study or has been treated with any investigational drugs within 90 days or 5 half-lives whichever is longer, prior to the initiation of screening
• Subject has a history of suicide attempt or suicidal behavior. Any recent suicidal ideation within the last 3 months (a level of 4 or 5 for any 1 item on the scale), or who are at significant risk to commit suicide, as judged by the Investigator using the C-SSRS at screening and on admission to the clinical unit on day -1.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Astellas Pharma Europe B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Central Contact

Role: STUDY_CHAIR

Astellas Pharma Europe B.V.

Locations

Parexel Early Phase Clinical Unit London

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

2013-001738-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

7962-CL-0001

Identifier Type: -

Identifier Source: org_study_id