Tolerability and Safety of Duloxetine BID in Healthy Female Subjects

NCT02232542 | Completed Phase 1

• 1 other identifier: 1208.1
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Assessment of tolerability by investigator on a 4-point scale

  Up to day 14 after drug administration

• Number of subjects with adverse events

  Up to day 14 after drug administration

• Number of subjects with clinically relevant findings in electrocardiogram (ECG)

  Up to day 14 after drug administration

• Number of subjects with clinically relevant findings in vital signs

  systolic and diastolic blood pressure

  Up to day 14 after drug administration

• Number of subjects with abnormal changes in laboratory parameters

  Up to day 14 after drug administration

Study Arms (3)

Duloxetine - low dose

EXPERIMENTAL

Drug: Duloxetine - low dose

Duloxetine - high dose

EXPERIMENTAL

Drug: Duloxetine - high dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Duloxetine - low dose DRUG

Duloxetine - low dose

Duloxetine - high dose DRUG

Duloxetine - high dose

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Duloxetine Hydrochloride

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 5, 2014
• Study Start: June 1, 2003
• Primary Completion: August 1, 2003
• Last Updated: September 5, 2014

Record last verified: 2014-08