Clinical trial NCT01675518: A Study to Assess the Safety, Pharmacological Effect and Plasma Concentration of ASP7991 After Single Oral Administration to Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Pharmacokinetics of ASP7991
Keywords: Plasma concentration
ASP7991
food effect
PTH (parathyroid hormone)
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-08-30
Enrollment: 56
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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 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)

Primary outcomes:
measure: The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs and Holter ECGs
timeFrame: for 96 hours after dosing
Secondary outcomes:
measure: Plasma Concentration of unchanged drug :Cmax, tmax, AUClast, AUCinf, t1/2, CL/F
timeFrame: for 96 hours after dosing
measure: Urinary concentrations of unchanged drug: Aelast，Aelast%, CLr
timeFrame: for 96 hour after dosing
measure: plasma parathyroid hormon concentration
timeFrame: for 96 hours after dosing
Other outcomes:
Locations:
city: Kantou
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: