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Multiple Oral Administration of ASP7991 to Non-elderly Male Subjects

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ClinicalTrials.gov Identifier: NCT01872013
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : June 7, 2013
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after multiple oral administrations to non-elderly subjects.

Condition or disease Intervention/treatment Phase
Healthy Pharmacokinetics of ASP7991 Drug: ASP7991 Drug: Placebo Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Randomized, Double-blinded, Placebo-controlled, Multiple Oral Administration of ASP7991 to Non-elderly Male Subjects
Study Start Date : November 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Arm Intervention/treatment
Experimental: low dose ASP7991 Drug: ASP7991
oral

Experimental: middle dose ASP7991 Drug: ASP7991
oral

Experimental: high dose ASP7991 Drug: ASP7991
oral

Placebo Comparator: Placebo Drug: Placebo
oral




Primary Outcome Measures :
  1. 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 [ Time Frame: For 96 hours after dosing ]

Secondary Outcome Measures :
  1. Plasma concentrations unchanged drug; AUC24h, Cmax, Ctrough, tmax, t1/2, CL/F, Vz/F [ Time Frame: For 96 hours after dosing ]
  2. Urinary concentrations unchanged drug; Aelast, Aelast%, CLR [ Time Frame: For 96 hours after dosing ]


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

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): NCT01872013


Locations
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Japan
Tokyo, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Medical Director Astellas Pharma Inc

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01872013     History of Changes
Other Study ID Numbers: 7991-CL-1002
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: June 7, 2013
Last Verified: June 2013

Keywords provided by Astellas Pharma Inc:
Plasma concentration
Urinary concentration
ASP7991