CompletedNCT02256878Updated Oct 6, 2014

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

A Phase 1 interventional study of BIRT 2584 XX and Amitriptyline in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-06.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 24
Allocation: Non-randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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 studied

Healthy

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 24 participants (actual)

Study arms

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

Interventions

DrugBIRT 2584 XX
DrugAmitriptyline
Also known as: Saroten®

What researchers measure

Primary outcomes

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
AUC0-∞ ratio of amitriptyline/nortriptyline
Time frame: up to 15 days

Secondary outcomes

AUC0-∞ of amitriptyline (area under the concentration-time curve of amitriptyline in plasma over the time interval from 0 extrapolated to infinity)
1 hour after BIRT 2584 XX
Time frame: Day 1
Cmax of amitriptyline (maximum concentration of amitriptyline in plasma)
Time frame: 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)
Time frame: up to 15 days
Cmax of nortriptyline (maximum concentration of nortriptyline in plasma)
Time frame: up to 15 days
AUC0-∞ ratio of amitriptyline/nortriptyline
1 hour after BIRT 2584 XX
Time frame: Day 1
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
tmax (time from dosing to the maximum concentration of the analytes in plasma)
Time frame: up to 15 days
λz (terminal rate constant of the analytes in plasma)
Time frame: up to 15 days
t1/2 (terminal half-life of the analytes in plasma)
Time frame: up to 15 days
MRTpo (mean residence time of the analytes in the body after po administration)
Time frame: up to 15 days
CL/F (apparent clearance of the analytes in the plasma after extravascular administration)
Time frame: up to 15 days
Vz/F (apparent volume of distribution during the terminal phase following an extravascular dose)
Time frame: up to 15 days
Pre-dose levels of BIRT 2584 XX and BI 610100
Time frame: up to 15 days
Number of subjects with adverse events
Time frame: up to 57 days
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 28 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: Day 28

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 6, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02256878
Lead sponsor: Boehringer Ingelheim
Responsible party: Sponsor
First posted: Oct 6, 2014
Start date: Aug 2004
Primary completion: Nov 2006
Last update: Oct 6, 2014

View the source record on ClinicalTrials.gov ↗

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