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

NCT02256878 | Completed Phase 1

• 1 other identifier: 1206.12
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC0-∞ of amitriptyline (area under the concentration-time curve of amitriptyline in plasma over the time interval from 0 extrapolated to infinity)

  up to 15 days

• AUC0-∞ ratio of amitriptyline/nortriptyline

  up to 15 days

Secondary Outcomes (16)

• AUC0-∞ of amitriptyline (area under the concentration-time curve of amitriptyline in plasma over the time interval from 0 extrapolated to infinity)

  Day 1

• Cmax of amitriptyline (maximum concentration of amitriptyline in plasma)

  up to 15 days

• AUC0-∞ of nortriptyline (area under the concentration-time curve of nortriptyline in plasma over the time interval from 0 extrapolated to infinity)

  up to 15 days

• Cmax of nortriptyline (maximum concentration of nortriptyline in plasma)

  up to 15 days

• AUC0-∞ ratio of amitriptyline/nortriptyline

  Day 1

Study Arms (1)

BIRT 2584 XX + Amitriptyline

EXPERIMENTAL

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

Interventions

BIRT 2584 XX DRUG

BIRT 2584 XX + Amitriptyline

Amitriptyline DRUG

Also known as: Saroten®

BIRT 2584 XX + Amitriptyline

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Amitriptyline

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 6, 2014
• Study Start: August 1, 2004
• Primary Completion: November 1, 2006
• Last Updated: October 6, 2014

Record last verified: 2014-10