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Completed

NCT Number: NCT02632331

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

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.

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Key information

Conditions

Age range

20 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fukuoka, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASP8825

Drug

Oral

Other names: gabapentin enacarbil

Primary outcomes

  1. Pharmacokinetics (PK) parameter of gabapentin: Cmax

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

    Cmax: Maximum concentration

  2. PK parameters of gabapentin: AUClast

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

    AUClast: Area under the concentration-time curve from the time of dosing extrapolated to the last measurable concentration

  3. Safety assessed by AEs

    Time frame: Up to 8 days after the final study drug dosing

    AEs: Adverse Events

  4. Safety assessed by Vital signs

    Time frame: Up to 3 days after the each study drug dosing

    Supine blood pressure, supine pulse rate and axillary body temperature

  5. Safety assessed by Laboratory tests

    Time frame: Up to 3 days after the each study drug dosing

    Hematology, blood biochemistry, and urinalysis

  6. Safety assessed by 12-lead ECGs

    Time frame: Up to 3 days after the each study drug dosing

    ECG: Electrocardiogram

Secondary outcomes

  1. PK parameters of gabapentin tmax

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

    tmax: Time of Cmax

  2. PK parameter of gabapentin: AUCinf

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

    AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity

  3. PK parameters of gabapentin: t1/2

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

    t1/2: Terminal elimination half-life

  4. PK parameters of gabapentin: CL/F

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

    CL/F: Apparent total systemic clearance

  5. PK parameters of gabapentin: MRTinf

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

    MRTinf: Mean residence time from the time of dosing extrapolated to time infinity

  6. PK parameters of gabapentin: MRTlast

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

    MRTlast: Mean residence time from the time of dosing extrapolated to the last measurable concentration

  7. PK parameters of gabapentin: kel

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

    kel: Terminal elimination rate constant

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 16, 2015
Registry last updated
Dec 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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