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

Safety Clinical Trial

Official title:

A Phase 1, Randomized, Subject- and Investigator-blinded, Sponsor-unblinded, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of ASP7962, Including a Food-effect Evaluation in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01981928
• Other study ID #: 7962-CL-0001
• Secondary ID: 2013-001738-16
• Status: Completed
• Phase: Phase 1
• First received: November 6, 2013
• Last updated: July 9, 2014
• Start date: November 2013
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pharmacokinetics of ASP7962
• Safety
• Tolerability

Intervention

Drug:
• ASP7962
Oral
• Placebo
Oral

Locations

Country	Name	City	State
United Kingdom	Parexel Early Phase Clinical Unit London	London

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessed by: clinical laboratory tests, vital signs, Electrocardiogram (ECG), Adverse Events (AEs), real time and continuous cardiac monitoring, orthostatic challenge test, and C-SSRS	Day 1 to End of Study Visit: Routine clinical laboratory tests (hematology, biochemistry [additionally including testosterone, luteinizing hormone {LH}, follicle-stimulating hormone {FSH}, inhibin b, sex hormone-binding globulin {SHBG}] and urinalysis), Vital Signs, ECG, A Es Day 1: Real-time cardiac monitoring Day 1 to Day 2: Continuous cardiac monitoring and orthostatic challenge test Day -1 and End of Study Visit: C-SSRS for suicidality risk	Day -1 through End of Study Visit (7 to 14 days after (early) discharge from the clinical unit (only after the second treatment period for subjects required to return for the food-effect part of the clinical study))	No
Secondary	Pharmacokinetics of ASP7962 in plasma and urine	Measurement of ASP7962 in plasma and urine under fasted and fed conditions. Plasma: AUCinf, AUCinf,u, AUClast, AUClast,u, Cmax, Cmax,u, CL/F, CLu/F, fu, tlag, tmax, t½, Vz/F, Vz,u/F Urine: Aelast, Aeinf, Aelast%, Aeinf%, CLR, CLR,u	Day 1 to Day 7	No