Study to Evaluate the Effect of Food Intake on the Plasma Concentration Changes of Quetiapine After Oral Administration of FK949E in Healthy Volunteers

NCT01871987 | Completed Phase 1

• 1 other identifier: 6949-CL-0003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A study to evaluate the effect of food on the plasma concentration changes of quetiapine after oral administration of FK949E (extended release formulation of quetiapine) in healthy male subjects.

Conditions

Healthy; Plasma Concentration Change of Quetiapine

Keywords

FK949E; Quetiapine; Antipsychotic

Outcome Measures

Primary Outcomes (2)

• Maximum plasma concentration (Cmax) of unchanged quetiapine

  For 48 hours after dosing

• AUC (area under the curve) of unchanged quetiapine

  For 48 hours after dosing

Secondary Outcomes (3)

• tmax of plasma concentration of unchanged quetiapine

  For 48 hours after dosing

• t1/2 of plasma concentration of unchanged quetiapine

  For 48 hours after dosing

• Safety assessed by the incidence of adverse events, clinical lab tests, vital signs, 12-lead ECGs and physical exam

  Up to 48 hours after each administration

Study Arms (3)

fasted group

EXPERIMENTAL

receiving FK949E in fasted condition

Drug: FK949E

low fat group

EXPERIMENTAL

receiving FK949E after low fat meal

Drug: FK949E

high fat group

EXPERIMENTAL

receiving FK949E after high fat meal

Drug: FK949E

Interventions

FK949E DRUG

oral

Also known as: extended release formulation of quetiapine

fasted group; high fat group; low fat group

Eligibility Criteria

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

You may qualify if:

• Body weight : ≥50.0 kg, \<85.0 kg
• Body Mass Index : ≥17.6, \<26.4
• Healthy, as judged by the investigator/subinvestigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained at screening and during the period from hospital admission in Period 1 to immediately before study medication

You may not qualify if:

• Subjects with the following history.
• Hepatic disease (e.g. viral hepatitis, drug-induced liver injury).
• Heart disease (e.g. congestive heart failure, angina pectoris, arrhythmia requiring
• treatment).
• Respiratory disease (e.g. serious bronchial asthma, chronic bronchitis)
• Gastrointestinal disease (e.g. serious peptic ulcer, gastroesophageal reflux esophagitis;
• diseases requiring several selections except for appendicitis)
• Renal disease (e.g. acute renal failure, glomerulonephritis, interstitial nephritis).
• Cerebrovascular disorder (e.g. cerebral infarction).
• Malignant tumor.
• Drug allergies. Allergic disorders (except for hay fever)
• Any use of drugs abuse. Alcohol abuse
• Any concurrent illness (except for caries)
• A deviation from the normal reference range of blood pressure, pulse rate, body temperature, or 12-lead ECG at screening or upon admission in Period 1 (day preceding the day of study medication).
• Any deviation of the following criteria for clinical laboratory tests at screening or upon admission in Period 1 (day preceding the day of study medication). The normal reference ranges specified at the study site will be used as the normal reference ranges in the present study.

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Kyushu, Japan

Location

Related Links

• Link to results on Astellas Clinical Study Results website

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 7, 2013
• Study Start: June 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: March 9, 2017

Record last verified: 2017-03

Locations

JP (1)