Clinical trial NCT02232542: Tolerability and Safety of Duloxetine BID in Healthy Female Subjects
Official title: Tolerability and Safety of 40 mg and 100 mg Duloxetine BID Given Over 7 Days in Healthy Female Subjects. A Randomised, Placebo-controlled Double-blind Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-05
Enrollment: 32
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of tolerability by investigator on a 4-point scale
timeFrame: Up to day 14 after drug administration
measure: Number of subjects with adverse events
timeFrame: Up to day 14 after drug administration
measure: Number of subjects with clinically relevant findings in electrocardiogram (ECG)
timeFrame: Up to day 14 after drug administration
measure: Number of subjects with clinically relevant findings in vital signs
timeFrame: Up to day 14 after drug administration
measure: Number of subjects with abnormal changes in laboratory parameters
timeFrame: Up to day 14 after drug administration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: