Clinical trial NCT02805374: A Food Effect Study to Evaluate the Pharmacokinetics of ASP1517
Official title: ASP1517 Pharmacokinetic Study - Evaluation of Food Effect on the Pharmacokinetics of ASP1517
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Pharmacokinetics
ASP1517
Food effect
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: FibroGen
First posted: 2016-06-20
Enrollment: 16
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to evaluate the effect of food on the pharmacokinetics of a single oral dose of ASP1517 in non-elderly healthy adult male subjects.


Eligibility criteria: Inclusion Criteria:

* Body weight: ≥50.0 kg and \<80.0 kg
* Body-mass index : ≥17.6 and \<26.4 kg/m2
* Subject must agree to use two of the established contraceptive methods after informed consent acquisition through 84 days after the last administration of the study drug.
* Subject must agree not to donate sperm after informed consent acquisition through 84 days after the last administration of the study drug.

Exclusion Criteria:

* Received or is scheduled to receive any investigational drugs in other clinical trials or post-marketing studies within 120 days before screening or during the period from screening to the hospital admission day of Period 1
* Received or is scheduled to receive medications (including over-the-counter \[OTC\] drugs) within 7 days before the hospital admission day of Period 1
* Received or is scheduled to receive supplements within 7 days before the hospital admission day of the Period 1
* Deviates from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram (ECG) at screening or the hospital admission day of Period 1
* Meets any of the criteria for laboratory tests at screening or the hospital admission day of Period 1. Normal ranges of each test specified at the test/assay organization will be used as the normal ranges in this study.
* Concurrent or previous drug allergies.
* Development of (an) upper gastrointestinal symptom(s) within seven days before the hospital admission day of Period 1.
* Concurrent or previous hepatic disease, heart disease, respiratory disease, gastrointestinal disease, renal disease, endocrine disease, cerebrovascular disorder, malignant tumor, retinal neovascular lesions and macular edema.
* A history of digestive tract excision.
* Previous use of hypoxia inducible factor-prolyl hydroxylase inhibitors (HIF-PHI) such as ASP1517 (FG-4592), YM311(FG-2216) or erythropoietin products.
* Excessive alcohol or smoking habit.

Primary outcomes:
measure: Pharmacokinetics (PK) parameter of ASP1517 in Plasma: AUCinf
timeFrame: Up to Day 4 of each treatment period
measure: PK parameter of ASP1517 in Plasma: Cmax
timeFrame: Up to Day 4 of each treatment period
Secondary outcomes:
measure: PK parameter of ASP1517 in Plasma: AUClast
timeFrame: Up to Day 4 of each treatment period
measure: PK parameter of ASP1517 in Plasma: CL/F
timeFrame: Up to Day 4 of each treatment period
measure: PK parameter of ASP1517 in Plasma: λz
timeFrame: Up to Day 4 of each treatment period
measure: PK parameter of ASP1517 in Plasma: MRTinf
timeFrame: Up to Day 4 of each treatment period
measure: PK parameter of ASP1517 in Plasma: t1/2
timeFrame: Up to Day 4 of each treatment period
measure: PK parameter of ASP1517 in Plasma: tmax
timeFrame: Up to Day 4 of each treatment period
measure: PK parameter of ASP1517 in Plasma: tlag
timeFrame: Up to Day 4 of each treatment period
measure: PK parameter of ASP1517 in Plasma: Vz/F
timeFrame: Up to Day 4 of each treatment period
measure: PK parameter of ASP1517 in Urine: Ae
timeFrame: Up to Day 4 of each treatment period
measure: PK parameter of ASP1517 in Urine: CLR
timeFrame: Up to Day 4 of each treatment period
measure: Safety assessed by adverse events
timeFrame: Up to Day 9 of Period 2
measure: Number of participants with abnormal vital signs and/or adverse events during treatment period
timeFrame: Up to Day 9 of Period 2
measure: Number of participants with abnormal laboratory values and/or adverse events during treatment period
timeFrame: Up to Day 9 of Period 2
measure: Number of participants with abnormal standard 12-Lead ECG and/or adverse events during treatment period
timeFrame: Up to Day 9 of Period 2
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Site JP00001
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: