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CompletedNCT01981928Updated Jul 11, 2014

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

A Phase 1 interventional study of ASP7962 and Placebo in Safety, Tolerability and Pharmacokinetics of ASP7962, sponsored by Astellas Pharma Europe B.V.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-11.

Sponsored by Astellas Pharma Europe B.V. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
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Study 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.

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Conditions studied

  • Safety
  • Tolerability
  • Pharmacokinetics of ASP7962

Keywords

  • Phase 1
  • Healthy Subjects
  • Safety
  • Tolerability
  • Pharmacokinetics
  • Single Ascending Oral Dose
  • Food Effect
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In context

Lead sponsor

Astellas Pharma Europe B.V. is the lead sponsor of 93 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    ASP7962

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

    Drug: ASP7962

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugASP7962

    Oral

  • DrugPlacebo

    Oral

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What researchers measure

Primary outcomes

  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

    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

    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))

Secondary outcomes

  1. 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

    Time frame: Day 1 to Day 7

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Study locations

1 site
  • Parexel Early Phase Clinical Unit London
    London, HA1 3UJ, United Kingdom
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01981928
Lead sponsor
Astellas Pharma Europe B.V.
Responsible party
Sponsor
First posted
Nov 13, 2013
Start date
Nov 2013
Primary completion
May 2014
Completion
May 2014
Last update
Jul 11, 2014

Study contacts

Central Contact
study chair · Astellas Pharma Europe B.V.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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