Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01675518
First received: August 28, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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 Intervention Phase
Healthy
Pharmacokinetics of ASP7991
Drug: ASP7991
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma Concentration of unchanged drug :Cmax, tmax, AUClast, AUCinf, t1/2, CL/F [ Time Frame: for 96 hours after dosing ] [ Designated as safety issue: No ]
    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

  • Urinary concentrations of unchanged drug: Aelast,Aelast%, CLr [ Time Frame: for 96 hour after dosing ] [ Designated as safety issue: No ]
    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

  • plasma parathyroid hormon concentration [ Time Frame: for 96 hours after dosing ] [ Designated as safety issue: No ]
    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


Enrollment: 56
Study Start Date: January 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 44 Years
Genders 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01675518

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

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01675518     History of Changes
Other Study ID Numbers: 7991-CL-0001
Study First Received: August 28, 2012
Last Updated: August 28, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on November 27, 2014