Multiple Rising Oral Doses of BI 1060469 in Healthy Subjects and Mild Asthma Patients

NCT02126865 | Completed Phase 1

• 2 other identifiers: 1333.22013-005463-10
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 1060469 in healthy male and female subjects after oral administration of repeated rising doses of 3 mg, 10 mg, 25 mg, 75 mg, 150 mg and 250 mg qd. of 1 day followed by 14 days and in asthmatic male and female patients after oral administration of repeated rising doses of 25 mg and 150 mg qd of 1 day followed by 28 days. Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality, dose linearity after single and multiple dose segments, pharmacodynamics (PD) of BI 1060469 and to describe the PK/PD relationship.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Percentage (%) of subjects with drug-related adverse events (AEs)

  Day 1 to 29 or Day 1 to Day 43 (end of trial)

Secondary Outcomes (7)

• AUCt,1 (area under the concentration-time curve of BI 1060469 in plasma over a uniform dosing interval t after administration of the first dose)

  0 to 672 hours or 0 to 1008 hours

• AUC0-infinity (area under the concentration-time curve of BI 1060469 in plasma over the time interval from 0 extrapolated to infinity)

  0 to 672 hours or 0 to 1008 hours

• Cmax (maximum measured concentration of BI 1060469 in plasma)

  0 to 672 hours or 0 to 1008 hours

• AUCt,ss (area under the concentration-time curve of BI 1060469 in plasma at steady state over a uniform dosing interval t)

  0 to 672 hours or 0 to 1008 hours

• Cpre,N (predose concentration of BI 1060469 in plasma immediately before administration of the Nth dose after N-1 doses were administered)

  0 to 672 hours or 0 to 1008 hours

Study Arms (4)

BI 1060469 Healthy

EXPERIMENTAL

Multiple rising dose qd for 15 days

Drug: BI 1060469 Healthy

Placebo to BI 1060469

PLACEBO COMPARATOR

Matching placebo as tablet for 15 days

Drug: Placebo to BI 1060469

BI 1060469 asthmatics

EXPERIMENTAL

Multiple rising dose qd for 29 days

Drug: BI 1060469 asthmatics

Placebo to BI 1060469 asthmatics

PLACEBO COMPARATOR

Matching placebo as tablet for 29 days

Drug: Placebo to BI 1060469 asthmatics

Interventions

Placebo to BI 1060469 DRUG

tablet

Placebo to BI 1060469

BI 1060469 Healthy DRUG

tablet

BI 1060469 Healthy

Placebo to BI 1060469 asthmatics DRUG

tablet

Placebo to BI 1060469 asthmatics

BI 1060469 asthmatics DRUG

tablet

BI 1060469 asthmatics

Eligibility Criteria

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

You may qualify if:

• Healthy or otherwise healthy asthmatic male or female subjects according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination,vital signs (BP, PR),12-lead ECG, and clinical laboratory tests
• Amended part under fed conditions:
• Healthy female subjects according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (BP, PR),12-lead ECG, and clinical laboratory tests.
• Age 18 to 55 years (incl.)
• BMI 18.5 to 29.9 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
• Male subjects,or females who meet any of the following criteria from at least 30 days before the first study drug administration and until 30 days after trial completion:
• surgically sterilised (including hysterectomy)
• postmenopausal defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)
• Amended part under fed conditions:
• Female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion:
• Use of adequate contraception, e.g. any of the following methods plus condom: implants,injectables,combined oral or vaginal contraceptives,intrauterine device
• Sexually abstinent
• A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
• Surgically sterilised (including hysterectomy)

You may not qualify if:

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator other than asthma up to GINA treatment step 2 or atopic diseases
• Repeated measurement of systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, or pulse rate outside the range of 50 to 90 mmHg
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Serum creatinine laboratory value out of the normal range
• GFR according to CKD-EPI-Formula \< 80 ml/ min at screening \[R12-1392\]
• Current or history of relevant kidney, urinay tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections)
• Any evidence of a concomitant disease judged clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)
• Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
• Intake of drugs with a long half-life (greater than 24 hours) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication
• Intake of any NSAIDs, COX2 inhibitors, aspirin, ACE-inhibitors, H2- blockers or OTCor nutripharmaceuticals between screening examination and drug administration

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1333.2.1 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

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: April 28, 2014
• First Posted: April 30, 2014
• Study Start: May 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 14, 2015

Record last verified: 2015-08

Locations

DE (1)