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

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ClinicalTrials.gov Identifier: NCT01981928
Recruitment Status : Completed
First Posted : November 13, 2013
Last Update Posted : July 11, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )

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.

Condition or disease Intervention/treatment Phase
Safety Tolerability Pharmacokinetics of ASP7962 Drug: ASP7962 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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
Study Start Date : November 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Arm Intervention/treatment
Experimental: ASP7962
Each dose level group will include 8 subjects, of which 6 will be randomized to receive active ASP7962
Drug: ASP7962
Oral

Placebo Comparator: Placebo
Each dose level group will include 8 subjects, of which 2 will be randomized to receive placebo
Drug: Placebo
Oral




Primary Outcome Measures :
  1. 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 [ Time Frame: 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)) ]
    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


Secondary Outcome Measures :
  1. Pharmacokinetics of ASP7962 in plasma and urine [ Time Frame: Day 1 to Day 7 ]
    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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981928


Locations
United Kingdom
Parexel Early Phase Clinical Unit London
London, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
Study Chair: Central Contact Astellas Pharma Europe B.V.

Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT01981928     History of Changes
Other Study ID Numbers: 7962-CL-0001
2013-001738-16 ( EudraCT Number )
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: July 11, 2014
Last Verified: July 2014

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):
Phase 1
Healthy Subjects
Safety
Tolerability
Pharmacokinetics
Single Ascending Oral Dose
Food Effect