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CompletedNCT02126826Updated Mar 25, 2019Results posted

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

A Phase 1 interventional study of BI 1026706 and Placebo to BI 1026706 in Osteoarthritis, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-25.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
35 Years to 65 Years
Sex
All
01

Study 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
02

Conditions studied

  • Osteoarthritis
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 58 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
58 participants (actual)

Study arms

  • Placebo comparator
    Placebo to BI 1026706

    Multiple Rising Doses Placebo to BI 1026706

    Drug: Placebo to BI 1026706

  • Experimental
    BI 1026706

    Multiple Rising Doses BI 1026706

    Drug: BI 1026706

Interventions

  • DrugBI 1026706

    Multiple Rising Doses (oral solution, tablet)

  • DrugPlacebo to BI 1026706

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

06

What researchers measure

Primary outcomes

  1. Percentage of Subjects With Drug Related Adverse Events

    Percentage of subjects with drug related adverse events (AEs)

    Time frame: From first drug administration until 3 days after last drug administration, 15 days

Secondary outcomes

  1. Maximum Measured Concentration (Cmax)

    Maximum measured concentration of the analyte in plasma (Cmax)

    Time frame: 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

  2. Time From Dosing to Maximum Measured Concentration (Tmax)

    Time from dosing to maximum measured concentration of the analyte in plasma (Tmax)

    Time frame: 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.

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

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 24 hours (h) (AUC0-24).

    Time frame: 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

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

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 12 hours (h) (AUC0-12).

    Time frame: 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

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

    Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval τ (Cmax,ss).

    Time frame: 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

  6. Time From Last Dosing to Maximum Measured Concentration at Steady-state (Tmax,ss)

    Time from last dosing to maximum concentration of the analyte in plasma at steady-state (Tmax,ss).

    Time frame: 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

  7. Area Under the Concentration-time Curve at Steady-state (AUCτ,ss)

    Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ (AUCτ,ss).

    Time frame: 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

07

Results

Posted Mar 25, 2019

Participant flow

Participant flow — Overall Study
MilestonePlacebo HV50mg BI 1026706 HV100mg BI 1026706 HV300mg BI 1026706 HVPlacebo OA200mg BI 1026706 OA100mg BI 1026706 BID OA
Started9999598
Completed9998598
Not completed0001000
Withdrew: Withdrawal by subject0001000

Outcome measures

PrimaryPercentage of Subjects With Drug Related Adverse Events

Percentage of subjects with drug related adverse events (AEs)

Time frame:
From first drug administration until 3 days after last drug administration, 15 days
Reported as:
Number · Percentage of participants
Percentage of Subjects With Drug Related Adverse Events
Percentage of participantsPlacebo HV50mg BI 1026706 HV100mg BI 1026706 HV300mg BI 1026706 HVPlacebo OA200mg BI 1026706 OA100mg BI 1026706 BID OA
Percentage of Subjects With Drug Related Adverse Events22.222.211.166.760.055.637.5
SecondaryMaximum Measured Concentration (Cmax)

Maximum measured concentration of the analyte in plasma (Cmax)

Time frame:
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
Reported as:
Geometric mean · nmol/L
Maximum Measured Concentration (Cmax)
nmol/L50mg BI 1026706 HV100mg BI 1026706 HV300mg BI 1026706 HV200mg BI 1026706 OA100mg BI 1026706 BID OA
Maximum Measured Concentration (Cmax)423 ± 31.21010 ± 25.31600 ± 54.31730 ± 36.1578 ± 53.6
Statistical analysis
  • 50mg BI 1026706 HV vs 100mg BI 1026706 HV vs 300mg BI 1026706 HV vs 200mg BI 1026706 OA · ANCOVA · Slope: 0.7865 · 90% CI 0.6193 to 0.9537
  • 50mg BI 1026706 HV vs 100mg BI 1026706 HV vs 200mg BI 1026706 OA · ANCOVA · Slope: 1.0171 · 90% CI 0.8378 to 1.1964
SecondaryTime From Dosing to Maximum Measured Concentration (Tmax)

Time from dosing to maximum measured concentration of the analyte in plasma (Tmax)

Time frame:
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.
Reported as:
Median · hours
Time From Dosing to Maximum Measured Concentration (Tmax)
hours50mg BI 1026706 HV100mg BI 1026706 HV300mg BI 1026706 HV200mg BI 1026706 OA100mg BI 1026706 BID OA
Time From Dosing to Maximum Measured Concentration (Tmax)0.52 (0.47 to 2.00)0.52 (0.33 to 0.98)0.69 (0.37 to 2.53)0.75 (0.50 to 1.08)1.53 (0.75 to 8.13)
SecondaryArea Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 24h (AUC0-24)

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 24 hours (h) (AUC0-24).

Time frame:
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
Reported as:
Geometric mean · nmol*h/L
Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 24h (AUC0-24)
nmol*h/L50mg BI 1026706 HV100mg BI 1026706 HV300mg BI 1026706 HV200mg BI 1026706 OA100mg BI 1026706 BID OA
Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 24h (AUC0-24)1230 ± 44.92790 ± 26.76410 ± 66.25530 ± 44.92790 ± 58.5
Statistical analysis
  • 50mg BI 1026706 HV vs 100mg BI 1026706 HV vs 300mg BI 1026706 HV vs 200mg BI 1026706 OA · ANCOVA · Slope: 0.9511 · 90% CI 0.7654 to 1.1367
  • 50mg BI 1026706 HV vs 100mg BI 1026706 HV vs 200mg BI 1026706 OA · ANCOVA · Slope: 1.0834 · 90% CI 0.8655 to 1.3013
SecondaryArea Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 12h (AUC0-12)

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 12 hours (h) (AUC0-12).

Time frame:
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
Reported as:
Geometric mean · nmol*h/L
Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 12h (AUC0-12)
nmol*h/L50mg BI 1026706 HV100mg BI 1026706 HV300mg BI 1026706 HV200mg BI 1026706 OA100mg BI 1026706 BID OA
Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 12h (AUC0-12)1050 ± 41.32370 ± 27.85080 ± 63.64720 ± 45.12290 ± 54.2
SecondaryMaximum Measured Concentration at Steady-state (Cmax,ss)

Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval τ (Cmax,ss).

Time frame:
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
Reported as:
Geometric mean · nmol/L
Maximum Measured Concentration at Steady-state (Cmax,ss)
nmol/L50mg BI 1026706 HV100mg BI 1026706 HV300mg BI 1026706 HV200mg BI 1026706 OA100mg BI 1026706 BID OA
Maximum Measured Concentration at Steady-state (Cmax,ss)485 ± 37.41190 ± 26.11800 ± 43.32040 ± 27.0723 ± 65.1
Statistical analysis
  • 50mg BI 1026706 HV vs 100mg BI 1026706 HV vs 300mg BI 1026706 HV vs 200mg BI 1026706 OA · ANCOVA · Slope: 0.7832 · 90% CI 0.6235 to 0.9428
  • 50mg BI 1026706 HV vs 100mg BI 1026706 HV vs 200mg BI 1026706 OA · ANCOVA · Slope: 1.0365 · 90% CI 0.8593 to 1.2137
SecondaryTime From Last Dosing to Maximum Measured Concentration at Steady-state (Tmax,ss)

Time from last dosing to maximum concentration of the analyte in plasma at steady-state (Tmax,ss).

Time frame:
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
Reported as:
Median · hours
Time From Last Dosing to Maximum Measured Concentration at Steady-state (Tmax,ss)
hours50mg BI 1026706 HV100mg BI 1026706 HV300mg BI 1026706 HV200mg BI 1026706 OA100mg BI 1026706 BID OA
Time From Last Dosing to Maximum Measured Concentration at Steady-state (Tmax,ss)0.53 (0.30 to 1.00)0.52 (0.35 to 1.02)0.58 (0.45 to 1.02)0.58 (0.33 to 1.05)1.13 (0.73 to 3.03)
SecondaryArea Under the Concentration-time Curve at Steady-state (AUCτ,ss)

Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ (AUCτ,ss).

Time frame:
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
Reported as:
Geometric mean · nmol*h/L
Area Under the Concentration-time Curve at Steady-state (AUCτ,ss)
nmol*h/L50mg BI 1026706 HV100mg BI 1026706 HV300mg BI 1026706 HV200mg BI 1026706 OA100mg BI 1026706 BID OA
Area Under the Concentration-time Curve at Steady-state (AUCτ,ss)1610 ± 51.44080 ± 24.58550 ± 44.57200 ± 38.93280 ± 61.3
Statistical analysis
  • 50mg BI 1026706 HV vs 100mg BI 1026706 HV vs 300mg BI 1026706 HV vs 200mg BI 1026706 OA · ANCOVA · Slope: 0.9433 · 90% CI 0.7744 to 1.1122
  • 50mg BI 1026706 HV vs 100mg BI 1026706 HV vs 200mg BI 1026706 OA · ANCOVA · Slope: 1.0810 · 90% CI 0.8583 to 1.3037

Adverse events

Collected over From first drug administration until 3 days after last drug administration, 15 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo HV—0/9 (0%)5/9 (55.6%)
50mg BI 1026706 HV—0/9 (0%)3/9 (33.3%)
100mg BI 1026706 HV—0/9 (0%)2/9 (22.2%)
300mg BI 1026706 HV—0/9 (0%)6/9 (66.7%)
Placebo OA—0/5 (0%)3/5 (60%)
200mg BI 1026706 OA—0/9 (0%)6/9 (66.7%)
100mg BI 1026706 BID OA—0/8 (0%)4/8 (50%)
Most frequent other events
Showing 10 of 36
Most frequent other events
EventPlacebo HV50mg BI 1026706 HV100mg BI 1026706 HV300mg BI 1026706 HVPlacebo OA200mg BI 1026706 OA100mg BI 1026706 BID OA
HeadacheNervous system disorders0/91/90/92/92/53/90/8
Abdominal distensionGastrointestinal disorders2/90/90/91/91/51/90/8
Abdominal pain upperGastrointestinal disorders0/90/90/92/90/52/90/8
Abnormal faecesGastrointestinal disorders1/91/90/92/90/52/90/8
DiarrhoeaGastrointestinal disorders0/90/90/92/91/51/90/8
FlatulenceGastrointestinal disorders1/90/90/92/90/50/91/8
DizzinessNervous system disorders0/90/90/92/90/51/91/8
Back painMusculoskeletal and connective tissue disorders0/90/91/90/91/51/90/8
Vision blurredEye disorders0/90/90/90/90/50/91/8
Abdominal painGastrointestinal disorders0/90/90/90/90/50/91/8

Baseline characteristics

Treated set (TS) which included all randomised patients and healthy subjects who received at least 1 dose of study medication.

Age, Continuous
Age, Continuous(Years)Placebo HV50mg BI 1026706 HV100mg BI 1026706 HV300mg BI 1026706 HVPlacebo OA200mg BI 1026706 OA100mg BI 1026706 BID OATotal
Mean48.3 ± 9.643.6 ± 5.350.1 ± 11.848.7 ± 8.850.2 ± 10.849.8 ± 8.458.1 ± 4.949.7 ± 9.2
Sex: Female, Male
Sex: Female, Male(Participants)Placebo HV50mg BI 1026706 HV100mg BI 1026706 HV300mg BI 1026706 HVPlacebo OA200mg BI 1026706 OA100mg BI 1026706 BID OATotal
Female644432528
Male355527330
08

Study locations

1 site
  • 1320.2.2 Boehringer Ingelheim Investigational Site
    Berlin, Germany
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02126826
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Apr 30, 2014
Start date
May 28, 2014
Primary completion
Oct 1, 2014
Completion
Oct 21, 2014
Results posted
Mar 25, 2019
Last update
Mar 25, 2019

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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