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

NCT ID: NCT02126826

Last Updated: 2019-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-28
• Study Completion Date: 2014-10-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo to BI 1026706

Multiple Rising Doses Placebo to BI 1026706

Group Type: PLACEBO_COMPARATOR

Placebo to BI 1026706

Intervention Type: DRUG

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

BI 1026706

Multiple Rising Doses BI 1026706

Group Type: EXPERIMENTAL

BI 1026706

Intervention Type: DRUG

Multiple Rising Doses (oral solution, tablet)

Interventions

BI 1026706

Multiple Rising Doses (oral solution, tablet)

Intervention Type: DRUG

Placebo to BI 1026706

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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

2. 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

3. For OA patients: American Rheumatism Association (ARA) functional class I, II, or III

4. 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

5. 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.

6. Age 35 to 65 years (inclusive)

7. BMI (Body Mass Index) 18.5 to 33 kg/m2 (inclusive)

8. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

9. 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)

Exclusion Criteria

1. Any finding in the medical examination (including Blood Pressure, Pulse Rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator

2. Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg

3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

4. Any evidence of a concomitant disease judged clinically relevant by the investigator

5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

6. Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)

7. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1320.2.2 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Countries

Germany

Other Identifiers

2012-005690-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1320.2

Identifier Type: -

Identifier Source: org_study_id