Tolerability and Safety of Duloxetine BID in Healthy Female Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: Duloxetine - high dose; Drug: Duloxetine - low dose

• Registration Number: NCT02232542
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to assess the safety and tolerability of 100 mg of duloxetine BID compared to 40 mg of duloxetine BID or placebo for 7 days

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2003-08
• Status Verified: 2014-08
• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-04
• Last Update Submitted: 2014-09-04
• Study First Posted: 2014-09-05
• Last Update Posted: 2014-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

• Healthy female subjects as determined by results of screening
• Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• Age ≥ 40 years
• BMI ≥ 18.5 and ≤ 29.9 kg/m2

Exclusion Criteria

• Any finding at any of the medical examinations (including blood pressure, pulse rate and ECG (electrocardiogram)) deviating from normal and of clinical relevance (resting heart rate greater than 100 bpm or tachyarrhythmia)
• History of or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders (except thyroid hormones and hormonal replacement therapy)
• History of relevant orthostatic hypotension, fainting spells and blackouts
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator, any bleeding disorder including prolonged or habitual bleeding, other hematologic disease, cerebral bleeding (e.g. after a car accident), commotio cerebri
• Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
• Use of any drugs that might influence the results of the trial (especially CYP2D6 or CYP1A2 modulating substances) within 2 weeks prior to administration or during the trial
• Participation in another trial with an investigational drug within 2 months prior to administration or during trial
• Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
• Alcohol abuse (> 60 g/day)
• Caffeine abuse (> 4 cups/day)
• Drug abuse
• Blood donation within 1 month prior to administration or during the trial
• Excessive physical activities within 10 days prior to administration or during the trial
• Any laboratory value outside the clinically accepted reference range
• Ineffective contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Duloxetine - high dose	Duloxetine - high dose	-
Duloxetine - low dose	Duloxetine - low dose	-

Primary Outcome Measures

Name	Time	Method
Number of subjects with clinically relevant findings in electrocardiogram (ECG)	Up to day 14 after drug administration
Number of subjects with adverse events	Up to day 14 after drug administration
Number of subjects with abnormal changes in laboratory parameters	Up to day 14 after drug administration
Number of subjects with clinically relevant findings in vital signs	Up to day 14 after drug administration	systolic and diastolic blood pressure
Assessment of tolerability by investigator on a 4-point scale	Up to day 14 after drug administration