NCT02126826 is a Phase 1 clinical trial of BI 1026706 in Osteoarthritis, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT02126826?

NCT02126826 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT02126826?

Interventions in NCT02126826: BI 1026706, Placebo to BI 1026706.

What condition does NCT02126826 study?

NCT02126826 studies Osteoarthritis.

Is NCT02126826 still recruiting?

NCT02126826 is currently completed. Last updated 25 March 2019.

Are results published for NCT02126826?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-03-25 · How we verify

NCT02126826

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 25 March 2019

What this trial tests

Phase 1 trial testing BI 1026706 in Osteoarthritis in 58 participants. Completed in 21 October 2014.

Timeline

28 May 2014

Primary endpoint
1 October 2014

21 October 2014

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	58
Start date	28 May 2014
Primary completion	1 October 2014
Estimated completion	21 October 2014
Sites	1 location across Germany

Drugs / interventions tested

BI 1026706 — full drug profile →
Placebo to BI 1026706 — full drug profile →

Conditions studied

Osteoarthritis — all drugs for Osteoarthritis →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 35 to 65, any sex, with Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Subjects With Drug Related Adverse Events Primary · From first drug administration until 3 days after last drug administration, 15 days

Percentage of subjects with drug related adverse events (AEs)

Group	Value	95% CI
Placebo HV	22.2
50mg BI 1026706 HV	22.2
100mg BI 1026706 HV	11.1
300mg BI 1026706 HV	66.7
Placebo OA	60.0
200mg BI 1026706 OA	55.6
100mg BI 1026706 BID OA	37.5

Maximum Measured Concentration (Cmax) Secondary · 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

Maximum measured concentration of the analyte in plasma (Cmax)

Group	Value	95% CI
50mg BI 1026706 HV	423	± 31.2
100mg BI 1026706 HV	1010	± 25.3
300mg BI 1026706 HV	1600	± 54.3
200mg BI 1026706 OA	1730	± 36.1
100mg BI 1026706 BID OA	578	± 53.6

Time From Dosing to Maximum Measured Concentration (Tmax) Secondary · 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 of the analyte in plasma (Tmax)

Group	Value	95% CI
50mg BI 1026706 HV	0.52	0.47 – 2.00
100mg BI 1026706 HV	0.52	0.33 – 0.98
300mg BI 1026706 HV	0.69	0.37 – 2.53
200mg BI 1026706 OA	0.75	0.50 – 1.08
100mg BI 1026706 BID OA	1.53	0.75 – 8.13

Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 24h (AUC0-24) Secondary · 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 of the analyte in plasma over the time interval from 0 extrapolated to 24 hours (h) (AUC0-24).

Group	Value	95% CI
50mg BI 1026706 HV	1230	± 44.9
100mg BI 1026706 HV	2790	± 26.7
300mg BI 1026706 HV	6410	± 66.2
200mg BI 1026706 OA	5530	± 44.9
100mg BI 1026706 BID OA	2790	± 58.5

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

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

Group	Value	95% CI
50mg BI 1026706 HV	1050	± 41.3
100mg BI 1026706 HV	2370	± 27.8
300mg BI 1026706 HV	5080	± 63.6
200mg BI 1026706 OA	4720	± 45.1
100mg BI 1026706 BID OA	2290	± 54.2

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

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

Group	Value	95% CI
50mg BI 1026706 HV	485	± 37.4
100mg BI 1026706 HV	1190	± 26.1
300mg BI 1026706 HV	1800	± 43.3
200mg BI 1026706 OA	2040	± 27.0
100mg BI 1026706 BID OA	723	± 65.1

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

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

Group	Value	95% CI
50mg BI 1026706 HV	0.53	0.30 – 1.00
100mg BI 1026706 HV	0.52	0.35 – 1.02
300mg BI 1026706 HV	0.58	0.45 – 1.02
200mg BI 1026706 OA	0.58	0.33 – 1.05
100mg BI 1026706 BID OA	1.13	0.73 – 3.03

Area Under the Concentration-time Curve at Steady-state (AUCτ,ss) Secondary · 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

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

Group	Value	95% CI
50mg BI 1026706 HV	1610	± 51.4
100mg BI 1026706 HV	4080	± 24.5
300mg BI 1026706 HV	8550	± 44.5
200mg BI 1026706 OA	7200	± 38.9
100mg BI 1026706 BID OA	3280	± 61.3

Adverse events — posted to ClinicalTrials.gov

Time frame: From first drug administration until 3 days after last drug administration, 15 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo HV

Serious: 0/9 (0%)

Deaths: —

50mg BI 1026706 HV

Serious: 0/9 (0%)

Deaths: —

100mg BI 1026706 HV

Serious: 0/9 (0%)

Deaths: —

300mg BI 1026706 HV

Serious: 0/9 (0%)

Deaths: —

Placebo OA

Serious: 0/5 (0%)

Deaths: —

200mg BI 1026706 OA

Serious: 0/9 (0%)

Deaths: —

100mg BI 1026706 BID OA

Serious: 0/8 (0%)

Deaths: —

Other adverse events (36 terms — click to expand)

Reaction	System	Placebo HV	50mg BI 1026706 HV	100mg BI 1026706 HV	300mg BI 1026706 HV	Placebo OA	200mg BI 1026706 OA	100mg BI 1026706 BID OA
Headache	Nervous system disorders	—	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—
Abnormal faeces	Gastrointestinal disorders	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—
Palpitations	Cardiac disorders	—	—	—	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—
Gastric disorder	Gastrointestinal disorders	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—
Pancreatic enzymes increased	Investigations	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—	—	—	—
Tension headache	Nervous system disorders	—	—	—	—	—	—	—
Agitation	Psychiatric disorders	—	—	—	—	—	—	—
Micturition urgency	Renal and urinary disorders	—	—	—	—	—	—	—
Menorrhagia	Reproductive system and breast disorders	—	—	—	—	—	—	—
Dysphonia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Haematoma	Vascular disorders	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT02126826 adverse events section.

Sponsor's own description

* 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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Pharmaceutical therapeutics for articular regeneration and restoration: state-of-the-art technology for screening small molecular drugs.
Chen Y, Sun H, Yao X, Yu Y, et al · · 2021 · cited 9× · PMID 34783870 · DOI 10.1007/s00018-021-03983-8

Verify or expand the search:

Other trials of BI 1026706

Trials testing the same drug.

NCT02652416 — Safety, Tolerability and Pharmacokinetics of BI 1026706 in Healthy Chinese and Japanese Male Volunteers · Phase 1 · completed
NCT02732951 — Safety and Effect on Central Retinal Thickness of BI 1026706 in Patients With Diabetic Macular Edema · Phase 2 · completed
NCT02657408 — Clinical Trial to Assess Pharmacodynamic Effects on Segmental Endotoxin Induced Inflammatory Response of BI 1026706 Vers · Phase 1 · completed
NCT02642614 — Safety, Tolerability and Pharmacokinetics and Effect on Inflammation of Oral BI 1026706 in Patients With COPD · Phase 1 · completed
NCT02513446 — Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 1026706 in Healthy Male Sub · Phase 1 · completed

Other recruiting trials for Osteoarthritis

Currently open trials in the same condition.

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NCT06631638 — EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) · NA · recruiting
NCT07198750 — "Bimodal vs Unimodal High-Intensity Pulsed Electromagnetic Field Therapy in Older Adults With Knee Osteoarthritis" · NA · recruiting
NCT07006714 — Preoperative Correction of Vitamin D Deficiency in Total Joint Arthroplasty (TJA) · Phase 4 · active not recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02126826 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 25 March 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02126826.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02126826

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of BI 1026706

Other recruiting trials for Osteoarthritis

Other Boehringer Ingelheim trials

Verify against primary sources