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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Osteoarthritis

Treatments

Drug: Placebo to BI 1026706

Drug: BI 1026706

Study type

Interventional

Funder types

Industry

Identifiers

NCT02126826

2012-005690-31 (EudraCT Number)

1320.2

Details and patient eligibility

About

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

Enrollment

58 patients

Sex

All

Ages

35 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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