Safety, Pharmacokinetics, and Pharmacodynamics of BIRT 2584 XX Administered as Multiple Doses and Safety and Pharmacokinetics of BIRT 2584 XX Administered With and Without Food as Single Dose to Healthy Male Volunteers

NCT02256761 | Completed Phase 1

• 1 other identifier: 1206.2
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study comprised two parts. The objective of the first study period was to assess the safety and pharmacokinetics of 500 mg of BIRT 2584 XX tablets administered with and without food in male healthy volunteers and to determine the relative bioavailability of the BIRT 2584 XX tablet formulation compared by historical comparison to BIRT 2584 XX powder in PEG 400 (U05-2074) (part 1). The second and major phase of the trial was aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising doses of BIRT 2584 XX (100 mg, 250 mg, and 500 mg bid on the first 2 days and qd on the following 12 days, or 750 mg qd for 28 days) in healthy male subjects (part 2)

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Number of subjects with abnormal findings in physical examination

  up to 45 days

• Number of subjects with abnormal changes in laboratory parameters

  up to 45 days

• Number of subjects with clinically significant changes in vital signs

  Pulse rate, systolic, and diastolic blood pressure

  up to 45 days

• Number of subjects with adverse events

  up to 59 days

• Number of subjects with clinically significant changes in 12-lead ECG

  up to 45 days

Secondary Outcomes (21)

• AUC0-inf (area under the concentration-time curve of BIRT 2584 XX in plasma over the time interval from 0 to infinity)

  up to 72 hours

• Cmax (maximum concentration of BIRT 2584 XX in plasma)

  up to 72 hours

• tmax (time from dosing to maximum concentration of BIRT 2584 XX and BI 610100, its major metabolite in humans)

  up to 72 hours

• Cmax (maximum concentration of BIRT 2584 XX and BI 610100 in plasma)

  up to 42 days

• tmax (time from dosing to maximum concentration of BIRT 2584 XX and BI 610100)

  up to 42 days

Study Arms (3)

BIRT 2584 XX - single dose

EXPERIMENTAL

Part 1 - bioavailability/food effect two single doses, 30 minutes prior to the second drug administration after a one week wash-out period, a standardised high fat, high caloric meal was served

Drug: BIRT 2584 XX - single dose; Other: high caloric meal

Placebo

PLACEBO COMPARATOR

Part 2

Drug: Placebo

BIRT 2584 XX - multiple escalating dose

EXPERIMENTAL

Part 2 - multiple escalating dose, 14 days and 28 days

Drug: BIRT 2584 XX - multiple escalating dose

Interventions

BIRT 2584 XX - multiple escalating dose DRUG

BIRT 2584 XX - multiple escalating dose

Placebo DRUG

Placebo

BIRT 2584 XX - single dose DRUG

BIRT 2584 XX - single dose

high caloric meal OTHER

30 minutes prior to the second drug administration after a one week wash-out period, a standardised high fat, high caloric meal was served

BIRT 2584 XX - single dose

Eligibility Criteria

• Age: 18 Years - 63 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects as determined by results of the screening
• Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• Age ≥ 18 and ≤ 63 years
• BMI ≥ 18.5 and ≤ 29.9 kg/m2

You may not qualify if:

• Any finding during the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematological, oncological, or hormonal disorders
• Surgery of gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (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) considered relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (greater than 24 hours) (less than 1 month prior to administration or during the trial)
• Use of any drugs, which might influence the results of the trial (less than 10 days prior to study drug administration or expected during the trial)
• Participation in another trial with an investigational drug (less than 2 months prior to administration or expected during trial)
• Smoker (more than 10 cigarettes/day or more than 3 cigars/day or more than 3 pipes/day)
• Alcohol abuse (more than 60 g of ethanol per day)
• Drug abuse
• Blood donation or loss greater than 400 mL (less than 1 month prior to administration or expected during the trial)
• Clinically relevant laboratory abnormalities

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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: October 2, 2014
• First Posted: October 6, 2014
• Study Start: January 1, 2005
• Primary Completion: July 1, 2005
• Last Updated: October 6, 2014

Record last verified: 2014-10