ASP8825 - A Study to Investigate the Food Effect on the Pharmacokinetics of ASP8825

Healthy Volunteers Clinical Trial

Official title:

Pharmacokinetic (PK) Study of ASP8825 - Evaluation of the Effect of Food on the Pharmacokinetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02632331
• Other study ID #: 8825-CL-0014
• Status: Completed
• Phase: Phase 1
• First received: December 14, 2015
• Last updated: December 14, 2015
• Start date: January 2009
• Est. completion date: February 2009

Study information

• Verified date: December 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the effect of food on the pharmacokinetics and safety after administration of ASP8825 in healthy non-elderly adult male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 44 Years

Eligibility

Inclusion Criteria:

• Body weight: =50.0 kg and <80.0 kg

• Body mass index BMI: =17.6 and <26.4 [BMI= Body weight (kg)/(Height (m))2]

Exclusion Criteria:

• Subjects who received any study drugs in other clinical trials or post-marketing studies within 120 days before screening

• Subjects who received or are scheduled to receive medications (including over-the-counter [OTC] drugs) within seven days before the hospital admission day of period 1.

• Subjects who deviate from the normal range of blood pressure, pulse rate, body temperature and standard 12-lead ECG at screening or the hospital admission day of period 1

• Subjects who meet 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 study site or the test/assay organization will be used as the normal ranges in this study.

• Subjects with a complication of drug allergies

• Subjects who developed upper gastrointestinal symptoms (e.g., nausea, vomiting, and stomachache) within seven days before the hospital admission day of period 1

• Subjects with a complication or history of hepatic disease (hepatitis viral and drug-induced liver injury, etc.)

• Subjects with a complication or history of heart disease (cardiac failure congestive, angina pectoris and arrhythmia requiring treatments, etc.)

• Subjects with a complication or history of respiratory disease (severe asthma bronchial and bronchitis chronic, etc.) (except for a history of non-severe infantile asthma)

• Subjects with a complication or history of alimentary disease (severe peptic ulcer, reflux esophagitis, etc.) (except for a history of appendicitis)

• Subjects with a complication or history of renal disease (acute kidney injury, glomerulonephritis, nephritis interstitial, etc.) (except for a history of calculus)

• Subjects with a complication or history of cerebrovascular disorder (cerebral infarction, etc.)

• Subjects with a complication or history of malignant tumor

• Subjects who have a habit of excessive alcohol drinking or smoking

• Subjects who previously received administration of ASP8825

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ASP8825
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK) parameter of gabapentin: Cmax	Cmax: Maximum concentration	Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing	No
Primary	PK parameters of gabapentin: AUClast	AUClast: Area under the concentration-time curve from the time of dosing extrapolated to the last measurable concentration	Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing	No
Primary	Safety assessed by AEs	AEs: Adverse Events	Up to 8 days after the final study drug dosing	No
Primary	Safety assessed by Vital signs	Supine blood pressure, supine pulse rate and axillary body temperature	Up to 3 days after the each study drug dosing	No
Primary	Safety assessed by Laboratory tests	Hematology, blood biochemistry, and urinalysis	Up to 3 days after the each study drug dosing	No
Primary	Safety assessed by 12-lead ECGs	ECG: Electrocardiogram	Up to 3 days after the each study drug dosing	No
Secondary	PK parameters of gabapentin tmax	tmax: Time of Cmax	Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing	No
Secondary	PK parameter of gabapentin: AUCinf	AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity	Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing	No
Secondary	PK parameters of gabapentin: t1/2	t1/2: Terminal elimination half-life	Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing	No
Secondary	PK parameters of gabapentin: CL/F	CL/F: Apparent total systemic clearance	Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing	No
Secondary	PK parameters of gabapentin: MRTinf	MRTinf: Mean residence time from the time of dosing extrapolated to time infinity	Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing	No
Secondary	PK parameters of gabapentin: MRTlast	MRTlast: Mean residence time from the time of dosing extrapolated to the last measurable concentration	Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing	No
Secondary	PK parameters of gabapentin: kel	kel: Terminal elimination rate constant	Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing	No