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Study to Evaluate the Effect Single and Multiple Oral Doses of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Amitriptyline and Nortriptyline in Healthy Male and Female Subjects

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ClinicalTrials.gov Identifier: NCT02256878
Recruitment Status : Completed
First Posted : October 6, 2014
Last Update Posted : October 6, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The objective of the study was evaluate that there is no clinically relevant interaction between amitriptyline (or its metabolite nortriptyline) and BIRT 2584 XX (or its metabolite BI 610100) when BIRT 2584 XX is administered as a tablet formulation to near steady state in an estimated high therapeutic dose. Pharmacokinetics (PK) of amitriptyline and nortriptyline were measured before dosing of BIRT 2584 XX, after the first dose of BIRT 2584 XX, and after repeated doses of BIRT 2584 XX near steady state

Condition or disease Intervention/treatment Phase
Healthy Drug: BIRT 2584 XX Drug: Amitriptyline Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Effect of a Single Oral Dose and Multiple Oral Doses of 500 mg of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Amitriptyline and Nortriptyline in Healthy Male and Female Subjects
Study Start Date : August 2004
Actual Primary Completion Date : November 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIRT 2584 XX + Amitriptyline

BIRT 2584 XX:

Days 1 and 2: twice daily (bid) Days 3 to 21: once daily (qd)

Amitriptyline:

Single dose on day -8, day 1, and day 15

Drug: BIRT 2584 XX
Drug: Amitriptyline
Other Name: Saroten®




Primary Outcome Measures :
  1. AUC0-∞ of amitriptyline (area under the concentration-time curve of amitriptyline in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 15 days ]
  2. AUC0-∞ ratio of amitriptyline/nortriptyline [ Time Frame: up to 15 days ]

Secondary Outcome Measures :
  1. AUC0-∞ of amitriptyline (area under the concentration-time curve of amitriptyline in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Day 1 ]
    1 hour after BIRT 2584 XX

  2. Cmax of amitriptyline (maximum concentration of amitriptyline in plasma) [ Time Frame: up to 15 days ]
  3. AUC0-∞ of nortriptyline (area under the concentration-time curve of nortriptyline in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 15 days ]
  4. Cmax of nortriptyline (maximum concentration of nortriptyline in plasma) [ Time Frame: up to 15 days ]
  5. AUC0-∞ ratio of amitriptyline/nortriptyline [ Time Frame: Day 1 ]
    1 hour after BIRT 2584 XX

  6. AUC0-tz (area under the concentration-time curve of the analytes in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: up to 15 days ]
  7. tmax (time from dosing to the maximum concentration of the analytes in plasma) [ Time Frame: up to 15 days ]
  8. λz (terminal rate constant of the analytes in plasma) [ Time Frame: up to 15 days ]
  9. t1/2 (terminal half-life of the analytes in plasma) [ Time Frame: up to 15 days ]
  10. MRTpo (mean residence time of the analytes in the body after po administration) [ Time Frame: up to 15 days ]
  11. CL/F (apparent clearance of the analytes in the plasma after extravascular administration) [ Time Frame: up to 15 days ]
  12. Vz/F (apparent volume of distribution during the terminal phase following an extravascular dose) [ Time Frame: up to 15 days ]
  13. Pre-dose levels of BIRT 2584 XX and BI 610100 [ Time Frame: up to 15 days ]
  14. Number of subjects with adverse events [ Time Frame: up to 57 days ]
  15. Number of subjects with abnormal changes in laboratory parameters [ Time Frame: up to 28 days ]
  16. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: Day 28 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy female or male volunteers as determined by the results of screening based upon a complete medical history, including physical examination, measurement of vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead ECG, and clinical laboratory tests
  • Age ≥ 18 and ≤ 55 years
  • BMI ≥ 18.5 and ≤ 29.9 kg/m2 (body mass index)
  • Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

  • Any finding of the medical examination (including BP, PR, and ECG) deviating from normal and of clinical relevance
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematologic, oncologic or hormonal disorders
  • Surgery of gastrointestinal tract (except appendectomy)
  • Diseases of the Central Nervous System (CNS) (such as epilepsy) or psychiatric disorders or neurological disorders
  • Relevant history of orthostatic hypotension, fainting spells or blackouts
  • Chronic or relevant acute infections
  • History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  • Intake of drugs with a long half-life (> 24 h) within 1 month prior to administration of the study drug or during the trial
  • Use of any drugs which might influence the results of the trial within 10 days prior to study drug administration or expected during the trial
  • Participation in another trial with an investigational drug within 2 months prior to administration or expected during the trial
  • Smoker (>10 cigarettes or >3 cigars or >3 pipes/day); inability to abstain from smoking within 5 days before first drug administration until completion of the trial
  • Alcohol abuse (>60 g/day)
  • Drug abuse
  • Blood donation or loss >400 mL, within 1 month prior to study drug administration or expected during the trial
  • Clinically relevant laboratory abnormalities

For male subjects:

  • Male subjects whose sexual partners are currently not using an adequate method of contraception that would prospectively be maintained during the study, are to be excluded
  • Male subjects who are not willing to use condoms are to be excluded

For female subjects:

  • Pregnancy
  • Positive pregnancy test
  • No highly safe method of contraception in women of childbearing potential (in this context, only sterilization or male partner sterilization is considered a highly safe method of contraception). Hormonal contraceptives are not considered adequate due to possible drug interaction with BIRT 2584 XX
  • Lactation period

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02256878     History of Changes
Other Study ID Numbers: 1206.12
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: October 6, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Amitriptyline
Amitriptyline, perphenazine drug combination
Nortriptyline
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants