Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1026706 in Male and Female Healthy Subjects and Patients With Osteoarthritis of the Knee

NCT02126826 | Completed Phase 1 Results

• 2 other identifiers: 1320.22012-005690-31
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

• To investigate the safety and tolerability of BI 1026706 in male and female healthy subjects and osteoarthritis (OA) patients following oral administration of repeated rising doses
• To explore the pharmacokinetics after multiple rising doses of BI 1026706 in male and female healthy subjects and OA patients
• The assessment of pharmacodynamics in OA patients

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Drug Related Adverse Events

  Percentage of subjects with drug related adverse events (AEs)

  From first drug administration until 3 days after last drug administration, 15 days

Secondary Outcomes (7)

• Maximum Measured Concentration (Cmax)

  1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin

• Time From Dosing to Maximum Measured Concentration (Tmax)

  1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin.

• Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 24h (AUC0-24)

  1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin

• Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 12h (AUC0-12)

  1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h and 12h after first drug admin

• Maximum Measured Concentration at Steady-state (Cmax,ss)

  5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12

Study Arms (2)

Placebo to BI 1026706

PLACEBO COMPARATOR

Multiple Rising Doses Placebo to BI 1026706

Drug: Placebo to BI 1026706

BI 1026706

EXPERIMENTAL

Multiple Rising Doses BI 1026706

Drug: BI 1026706

Interventions

BI 1026706 DRUG

Multiple Rising Doses (oral solution, tablet)

BI 1026706

Placebo to BI 1026706 DRUG

Multiple Rising Doses (oral solution / tablet, identical to active treatment)

Placebo to BI 1026706

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females without any clinically relevant medical disorders according to the investigator's assessment, as based on the following: a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
• For OA patients: Evidence of OA of the knee by radiography or by magnetic resonance tomography (Kellgren-Lawrence grade 1, 2, or 3; excluding grades 0 and 4) of the knee (tibiofemoral joint only) within the last 5 years consistent with the clinical diagnosis of osteoarthritis of the knee according to American College of Rheumatology (ACR) guidelines
• For OA patients: American Rheumatism Association (ARA) functional class I, II, or III
• For OA patients: Average pain in the index knee over the previous 48 hours greater than or equal to 4 on the 11-item Likert scale at two time points: 1) at screening (if not on analgesic medication) or after 3 days of wash-out of analgesic medication, and 2) in the evening prior to randomisation
• For OA patients: Presence of bothersome OA related pain for most days within the last month prior to screening at the investigator's discretion, or pain requiring analgesic treatment on more than 3 days per week during the last month prior to screening.
• Age 35 to 65 years (inclusive)
• BMI (Body Mass Index) 18.5 to 33 kg/m2 (inclusive)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
• 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:
• using adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral contraceptives, intrauterine device (IUD)
• sexually abstinent
• have a vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
• 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 (Follicle Stimulating Hormon) above 40 U/L and estradiol below 30 ng/L is confirmatory)

You may not qualify if:

• Any finding in the medical examination (including Blood Pressure, Pulse Rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator
• Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1320.2.2 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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 28, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 21, 2014
• Last Updated: March 25, 2019
• Results First Posted: March 25, 2019

Record last verified: 2018-12

Locations

DE (1)