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

Healthy Clinical Trial

Official title:

Pharmacokinetic Study of FK949E -A Pharmacokinetic Study in Healthy Male Volunteers to Investigate the Effect of Food on the Pharmacokinetics of FK949E

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01871987
• Other study ID #: 6949-CL-0003
• Status: Completed
• Phase: Phase 1
• First received: June 5, 2013
• Last updated: March 7, 2017
• Start date: June 2009
• Est. completion date: August 2009

Study information

• Verified date: March 2017
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a 3-way cross-over study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 44 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Subjects with the following history.

1. Hepatic disease (e.g. viral hepatitis, drug-induced liver injury).

2. Heart disease (e.g. congestive heart failure, angina pectoris, arrhythmia requiring

treatment).

3. Respiratory disease (e.g. serious bronchial asthma, chronic bronchitis)

4. Gastrointestinal disease (e.g. serious peptic ulcer, gastroesophageal reflux esophagitis;

diseases requiring several selections except for appendicitis)

5. Renal disease (e.g. acute renal failure, glomerulonephritis, interstitial nephritis).

6. Cerebrovascular disorder (e.g. cerebral infarction).

7. Malignant tumor.

8. Drug allergies. Allergic disorders (except for hay fever)

9. 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.

1. Hematology:

• A deviation of ±20% from the upper or lower limit of the normal range

2. Blood biochemistry:

• A deviation from the normal range for AST, ALT, creatinine (Cre), or serum electrolytes.

• A deviation of ±20% from the upper or lower limit of the normal range for other items than the above.

• However, the lower limit of the normal range will not be established for items for which a deviation from the lower limit is not considered clinically significant[AST, ALT, total bilirubin (T-Bil), ALP, ?-GTP, LDH, CK, Cre, uric acid (UA)and total cholesterol (T-Cho)].

3. Urinalysis:

• U-Glu, U-Pro =+1

• U-Uro =+2

4. Urinary drug test: A positive result for phencyclidine, benzodiazepine, cocaine, amphetamines, cannabis, opiates, barbiturates or tricyclic antidepressants

5. Immunological test: A positive result for HBs antigen, HCV antibody, syphilis, or HIV antigen/antibody

• Received medication within 14 days before hospital admission in Period 1 or is scheduled to receive medication

• Received any investigational drugs in other clinical or post-marketing studies within 120 days before the screening assessment

• Previous treatment with FK949E

• Donated more than 400 mL of whole blood within 90 days, more than 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment

• Excessive smoking or drinking habit (measure of "excessive": alcohol: 45 g/day [a 633 mL bottle of beer contains 25 g of alcohol, and 180 mL of Japanese sake contains 22 g of alcohol], smoking: 20 cigarettes/day).

• Other subjects concerned ineligible by the investigator/subinvestigator

Related Conditions & MeSH terms

• Healthy
• Plasma Concentration Change of Quetiapine

Intervention

Drug:
• FK949E
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	Maximum plasma concentration (Cmax) of unchanged quetiapine		For 48 hours after dosing
Primary	AUC (area under the curve) of unchanged quetiapine		For 48 hours after dosing
Secondary	tmax of plasma concentration of unchanged quetiapine		For 48 hours after dosing
Secondary	t1/2 of plasma concentration of unchanged quetiapine		For 48 hours after dosing
Secondary	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

External Links

•   Link to results on Astellas Clinical Study Results website