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A Study to Assess the Safety, Pharmacological Effect and Plasma Concentration of ASP7991 After Single Oral Administration to Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01675518
Recruitment Status : Completed
First Posted : August 30, 2012
Last Update Posted : August 30, 2012
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 single oral administration to healthy volunteers. In part-1, ASP7991 is administered in a dose escalation design. In part-2, plasma concentration changes of ASP7991 in fasted and fed conditions are compared.

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

Detailed Description:

This study consists of two parts. In Part 1, the study will begin as a single rising dose escalation design under randomized double-blind and fasting conditions. In each dose group, volunteers will be randomized to receive an oral administration of either active drug (ASP7991) or placebo. The dose escalation will be determined after blinded safety assessment.

Part 2 is a study to evaluate the effect of food intake. ASP7991 will be administered to volunteers under 2 conditions, fasting and fed, on 2-way crossover method.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Phase 1 Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Oral Administration of ASP7991 in Healthy Volunteers
Study Start Date : January 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Arm Intervention/treatment
Experimental: Part-1 dose 1 Drug: ASP7991
oral
Experimental: Part-1 dose 2 Drug: ASP7991
oral
Experimental: Part-1 dose 3 Drug: ASP7991
oral
Experimental: Part-1 dose 4 Drug: ASP7991
oral
Experimental: Part-1 dose 5 Drug: ASP7991
oral
Experimental: Part-1 dose 6 Drug: ASP7991
oral
Placebo Comparator: Part-1 placebo Drug: Placebo
oral
Experimental: Part-2 fed Drug: ASP7991
oral
Experimental: Part-2 fasted Drug: ASP7991
oral



Primary Outcome Measures :
  1. The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs and Holter ECGs [ Time Frame: for 96 hours after dosing ]

Secondary Outcome Measures :
  1. Plasma Concentration of unchanged drug :Cmax, tmax, AUClast, AUCinf, t1/2, CL/F [ Time Frame: for 96 hours after dosing ]
    Blood samples are collected at the following times: redose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12,16, 24, 48, 72 and 96 hours

  2. Urinary concentrations of unchanged drug: Aelast,Aelast%, CLr [ Time Frame: for 96 hour after dosing ]
    Urine samples are collected at the following times: redose and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours

  3. plasma parathyroid hormon concentration [ Time Frame: for 96 hours after dosing ]
    Blood samples are collected at the following times: redose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12,16, 24, 48, 72 and 96 hours



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Ages Eligible for Study:   20 Years to 44 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): NCT01675518


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

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01675518     History of Changes
Other Study ID Numbers: 7991-CL-0001
First Posted: August 30, 2012    Key Record Dates
Last Update Posted: August 30, 2012
Last Verified: August 2012

Keywords provided by Astellas Pharma Inc:
Plasma concentration
ASP7991
food effect
PTH (parathyroid hormone)