Study to Evaluate the Effect of Multiple-dose of Fluvoxamine on the Plasma Concentration of Quetiapine (FK949E) in Healthy Male Volunteers

NCT01908296 | Completed Phase 1

• 1 other identifier: 6949-CL-0004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study was to assess the effect of multiple-dose fluvoxamine on the pharmacokinetics of quetiapine (FK949E) in healthy adult male subjects. The safety of FK949E in the population was also evaluated.

Conditions

Healthy; Pharmacokinetics of Quetiapine

Keywords

FK949E; fluvoxamine; Antipsychotic; Quetiapine

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 (11)

• 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.

• Maximum plasma concentration (Cmax) of quetiapine metabolites

  For 48 hours after dosing.

• AUC (area under the curve) of quetiapine metabolites

  For 48 hours after dosing.

• tmax of plasma concentration of quetiapine metabolites

  For 48 hours after dosing.

Study Arms (1)

FK949E group

EXPERIMENTAL

receiving FK949E with and without fluvoxamine

Drug: FK949E; Drug: fluvoxamine

Interventions

FK949E DRUG

Oral

Also known as: extended release formulation of quetiapine

FK949E group

fluvoxamine DRUG

Oral

Also known as: Luvox®

FK949E 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, \<80.0 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 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)
• Drug dependence, alcohol dependence
• Any disease (except dental caries)
• A deviation from the normal reference range of blood pressure, pulse rate, body temperature, or 12-lead ECG
• A deviation of the following criteria for clinical laboratory tests.

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

MeSH Terms

Interventions

Fluvoxamine

Intervention Hierarchy (Ancestors)

Oximes; Hydroxylamines; Amines; Organic Chemicals

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: July 25, 2013
• Study Start: July 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: February 16, 2017

Record last verified: 2017-02

Locations

JP (1)