Clinical trial NCT02952040: A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP1517 and Lanthanum Carbonate Hydrate
Official title: Pharmacokinetic Study of ASP1517 - Evaluation of the Effect of Lanthanum Carbonate Hydrate on the Pharmacokinetics of ASP1517 in Non-elderly Healthy Adult Male Subjects -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: ASP1517
Pharmacokinetics
Drug-drug interaction
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: FibroGen
First posted: 2016-11-02
Enrollment: 18
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 lanthanum carbonate hydrate on the pharmacokinetics (PK) of ASP1517 in non-elderly healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Body weight (at screening): ≥50.0 kg and \<80.0 kg
* Body-mass index (at screening): ≥17.6 and \<26.4 kg/m2 \[Body-mass index = Body weight (kg)/(Height (m))2\]
* Subject must agree to use contraception consisting of two established forms specified below starting at the time of informed consent and continuing throughout the treatment period and for 84 days after the last administration of ASP1517.
* Subject must agree not to donate sperm starting at the time of informed consent and continuing throughout 84 days after the last administration of ASP1517.

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 the Period 1.
* Received or is scheduled to receive medications (including over-the-counter drugs) or 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 at screening or the hospital admission day of the Period 1.
* Meets any of the following criteria for laboratory tests at screening or the hospital admission day of the Period 1. Normal ranges of each test specified at the study site or 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 7 days before the hospital admission day of the Period 1.
* Concurrent or previous hepatic disease, heart disease, respiratory disease, peritoneum inflammation.
* A history of abdominal surgery, digestive tract excision.
* Concurrent or previous renal disease, endocrine disease, cerebrovascular disorder, malignant tumor, retinal neovascular lesions.
* Previous use of hypoxia inducible factor-prolyl hydroxylase inhibitors (HIF-PHI) such as ASP1517 (FG-4592), YM311 (FG-2216), erythropoietin products or lanthanum carbonate hydrate.
* Excessive alcohol or smoking habit.

Primary outcomes:
measure: Pharmacokinetics (PK) parameter of ASP1517 in plasma: AUCINF
timeFrame: Up to 72hr after each dosing
measure: PK parameter of ASP1517 in plasma: AUC24h
timeFrame: Up to 72hr after each dosing
measure: PK parameter of ASP1517 in plasma: Cmax
timeFrame: Up to 72hr after each dosing
Secondary outcomes:
measure: PK parameter of ASP1517 in plasma: AUClast
timeFrame: Up to 72hr after each dosing
measure: PK parameter of ASP1517 in plasma: CL/F
timeFrame: Up to 72hr after each dosing
measure: PK parameter of ASP1517 in plasma: t1/2
timeFrame: Up to 72hr after each dosing
measure: PK parameter of ASP1517 in plasma: Lambda z
timeFrame: Up to 72hr after each dosing
measure: PK parameter of ASP1517 in plasma: MRTinf
timeFrame: Up to 72hr after each dosing
measure: PK parameter of ASP1517 in plasma: tmax
timeFrame: Up to 72hr after each dosing
measure: PK parameter of ASP1517 in plasma: tlag
timeFrame: Up to 72hr after each dosing
measure: PK parameter of ASP1517 in plasma: Vz/F
timeFrame: Up to 72hr after each dosing
measure: Safety assessed by incidence of adverse events
timeFrame: Up to 7 days after drug dosing of period 2
measure: Safety assessed by supine blood pressure
timeFrame: Up to 7 days after drug dosing of period 2
measure: Safety assessed by supine pulse rate
timeFrame: Up to 7 days after drug dosing of period 2
measure: Safety assessed by axillary body temperature
timeFrame: Up to 7 days after drug dosing of period 2
measure: Safety assessed by Laboratory tests: Hematology
timeFrame: Up to 7 days after drug dosing of period 2
measure: Safety assessed by Laboratory tests: Blood biochemistry
timeFrame: Up to 7 days after drug dosing of period 2
measure: Safety assessed by Laboratory tests: Urinalysis
timeFrame: Up to 7 days after drug dosing of period 2
measure: Safety assessed by 12-lead electrocardiogram
timeFrame: Up to 7 days after drug dosing 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: