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

NCT02632331 | Completed Phase 1

• 1 other identifier: 8825-CL-0014
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Food effect; Pharmacokinetics; ASP8825; XP13512

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• Safety assessed by AEs

  AEs: Adverse Events

  Up to 8 days after the final study drug dosing

• 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

• Safety assessed by Laboratory tests

  Hematology, blood biochemistry, and urinalysis

  Up to 3 days after the each study drug dosing

• Safety assessed by 12-lead ECGs

  ECG: Electrocardiogram

  Up to 3 days after the each study drug dosing

Secondary Outcomes (7)

• PK parameters of gabapentin tmax

  Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing

• PK parameter of gabapentin: AUCinf

  Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing

• PK parameters of gabapentin: t1/2

  Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing

• PK parameters of gabapentin: CL/F

  Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing

• PK parameters of gabapentin: MRTinf

  Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing

Study Arms (2)

Fasted dosing preceding group

EXPERIMENTAL

Drug: ASP8825

Fed dosing preceding group

EXPERIMENTAL

Drug: ASP8825

Interventions

ASP8825 DRUG

Oral

Also known as: gabapentin enacarbil

Fasted dosing preceding group; Fed dosing preceding group

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body weight: ≥50.0 kg and \<80.0 kg
• Body mass index BMI: ≥17.6 and \<26.4 \[BMI= Body weight (kg)/(Height (m))2\]

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Fukuoka, Japan

Location

MeSH Terms

Interventions

1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 16, 2015
• Study Start: January 1, 2009
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

JP (1)