NCT01763333 is a Phase 1 clinical trial of BI 1026706 in Healthy, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT01763333?

NCT01763333 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT01763333?

Interventions in NCT01763333: BI 1026706 Placebo, BI 1026706.

Is NCT01763333 still recruiting?

NCT01763333 is currently completed. Last updated 25 March 2019.

Are results published for NCT01763333?

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

NCT01763333

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

To Investigate the Safety, Tolerability, Pharmacokinetics and the Relative Bioavailability of BI 1026706

Completed Phase 1 Results posted Last updated 25 March 2019

What this trial tests

Phase 1 trial testing BI 1026706 Placebo in Healthy in 80 participants. Completed in 4 September 2013.

Timeline

8 January 2013

Primary endpoint
4 September 2013

4 September 2013

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	single
Primary purpose	treatment
Enrollment	80
Start date	8 January 2013
Primary completion	4 September 2013
Estimated completion	4 September 2013
Sites	1 location across Germany

Drugs / interventions tested

BI 1026706 Placebo
BI 1026706 — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 18 to 50, male only, with Healthy. 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.

Number of Subjects With Drug Related Adverse Events Primary · From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.

Percentage of subjects with drug related adverse events.

Group	Value	95% CI
BI 1026706 - Tablet 25 mg (SRD - Part)	0.0
BI 1026706 - Tablet 50 mg (SRD - Part)	33.3
BI 1026706 - Tablet 100 mg (SRD - Part)	16.7
BI 1026706 - Tablet 200 mg (SRD - Part)	16.7
BI 1026706 - Tablet 400 mg (SRD - Part)	25.0
BI 1026706 - Solution 10 mg (SRD - Part)	0.0
BI 1026706 - Solution 100 mg (SRD - Part)	20.0
BI 1026706 - Solution 200 mg (SRD - Part)	16.7
BI 1026706 - Solution 400 mg (SRD - Part)	60.0
Placebo (SRD - Part)	22.2
BI 1026706 - Solution 100 mg Fasted (R2)	0.0
BI 1026706 - 100 mg Solution Fed (T2)	8.3

Cmax Secondary · -2.0 hours (h) before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing

Maximum measured concentration of the analyte in plasma (Cmax). The treated set-SRD Part (TS-SRD) included all 68 subjects from the TS who participated in the SRD Part. The treated set-BA Part (TS-BA) included all 12 subjects from the TS who participated in the BA Part. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) included all subjects of the TS-BA who provided observations under the reference treatment (R1) or test treatment (T1) for at least one of the endpoints Cmax, AUC0-tz, or AUC0-inf,without experiencing emesis at or before two times m

Group	Value	95% CI
BI 1026706 - Tablet 25 mg (SRD - Part)	117	± 33.1
BI 1026706 - Tablet 50 mg (SRD - Part)	268	± 42.9
BI 1026706 - Tablet 100 mg (SRD - Part)	623	± 40.9
BI 1026706 - Tablet 200 mg (SRD - Part)	728	± 26.8
BI 1026706 - Tablet 400 mg (SRD - Part)	1430	± 80.0
BI 1026706 - Solution 10 mg (SRD - Part)	112	± 32.9
BI 1026706 - Solution 100 mg (SRD - Part)	1150	± 47.1
BI 1026706 - Solution 200 mg (SRD - Part)	2210	± 28.0
BI 1026706 - Solution 400 mg (SRD - Part)	3090	± 24.8
BI 1026706 - Solution 100 mg Fasted (R2)	1340	± 32.0
BI 1026706 - 100 mg Solution Fed (T2)	706	± 33.5
BI 1026706 - Tablet 100 mg Fasted (R1)	560	± 34.8

Tmax (Time From Dosing to Maximum Measured Concentration) Secondary · -2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing

Time from dosing to maximum measured concentration (tmax).

Group	Value	95% CI
BI 1026706 - Tablet 25 mg (SRD - Part)	1.74	0.75 – 4.07
BI 1026706 - Tablet 50 mg (SRD - Part)	1.51	1.00 – 3.00
BI 1026706 - Tablet 100 mg (SRD - Part)	1.75	0.73 – 4.02
BI 1026706 - Tablet 200 mg (SRD - Part)	1.25	0.76 – 4.02
BI 1026706 - Tablet 400 mg (SRD - Part)	2.23	1.00 – 3.00
BI 1026706 - Solution 10 mg (SRD - Part)	0.63	0.50 – 1.00
BI 1026706 - Solution 100 mg (SRD - Part)	0.50	0.50 – 0.76
BI 1026706 - Solution 200 mg (SRD - Part)	0.75	0.42 – 0.75
BI 1026706 - Solution 400 mg (SRD - Part)	0.75	0.42 – 1.00
BI 1026706 - Solution 100 mg Fasted (R2)	0.52	0.50 – 0.75
BI 1026706 - 100 mg Solution Fed (T2)	0.75	0.50 – 1.00
BI 1026706 - Tablet 100 mg Fasted (R1)	1.74	0.75 – 3.02

AUC0-inf Secondary · -2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing

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

Group	Value	95% CI
BI 1026706 - Tablet 25 mg (SRD - Part)	768	± 28.6
BI 1026706 - Tablet 50 mg (SRD - Part)	1690	± 51.8
BI 1026706 - Tablet 100 mg (SRD - Part)	3990	± 30.9
BI 1026706 - Tablet 200 mg (SRD - Part)	4040	± 29.4
BI 1026706 - Tablet 400 mg (SRD - Part)	8900	± 85.1
BI 1026706 - Solution 10 mg (SRD - Part)	428	± 41.9
BI 1026706 - Solution 100 mg (SRD - Part)	3220	± 43.5
BI 1026706 - Solution 200 mg (SRD - Part)	7790	± 26.9
BI 1026706 - Solution 400 mg (SRD - Part)	11300	± 28.3
BI 1026706 - Solution 100 mg Fasted (R2)	4590	± 33.1
BI 1026706 - 100 mg Solution Fed (T2)	3380	± 28.6
BI 1026706 - Tablet 100 mg Fasted (R1)	3270	± 28.3

AUC0- tz Secondary · -2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0- tz).

Group	Value	95% CI
BI 1026706 - Tablet 25 mg (SRD - Part)	741	± 25.2
BI 1026706 - Tablet 50 mg (SRD - Part)	1670	± 51.8
BI 1026706 - Tablet 100 mg (SRD - Part)	3950	± 30.5
BI 1026706 - Tablet 200 mg (SRD - Part)	3990	± 28.6
BI 1026706 - Tablet 400 mg (SRD - Part)	8830	± 85.3
BI 1026706 - Solution 10 mg (SRD - Part)	403	± 44.0
BI 1026706 - Solution 100 mg (SRD - Part)	3170	± 27.0
BI 1026706 - Solution 200 mg (SRD - Part)	7710	± 27.0
BI 1026706 - Solution 400 mg (SRD - Part)	11300	± 28.3
BI 1026706 - Solution 100 mg Fasted (R2)	4550	± 33.3
BI 1026706 - 100 mg Solution Fed (T2)	3360	± 28.9
BI 1026706 - Tablet 100 mg Fasted (R1)	3240	± 28.3

t1/2 (Terminal Half-life of the Analyte in Plasma) Secondary · -2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing

Terminal half-life of the analyte in plasma (t1/2).

Group	Value	95% CI
BI 1026706 - Tablet 25 mg (SRD - Part)	10.80	± 75.7
BI 1026706 - Tablet 50 mg (SRD - Part)	8.58	± 54.3
BI 1026706 - Tablet 100 mg (SRD - Part)	12.10	± 26.6
BI 1026706 - Tablet 200 mg (SRD - Part)	11.60	± 43.2
BI 1026706 - Tablet 400 mg (SRD - Part)	12.00	± 22.7
BI 1026706 - Solution 10 mg (SRD - Part)	13.90	± 82.1
BI 1026706 - Solution 100 mg (SRD - Part)	12.80	± 54.7
BI 1026706 - Solution 200 mg (SRD - Part)	11.50	± 50.3
BI 1026706 - Solution 400 mg (SRD - Part)	9.29	± 27.3
BI 1026706 - Solution 100 mg Fasted (R2)	10.80	± 36.0
BI 1026706 - 100 mg Solution Fed (T2)	11.10	± 53.9
BI 1026706 - Tablet 100 mg Fasted (R1)	10.50	± 46.9

f t1-t2 (SRD-Part) Secondary · 0-4, 4-8, 8-12, 12-24, 24-48, 48-72 hours

Fraction of analyte eliminated in urine from the time point t1 (0h) to time point t2 (72h) (f t1-t2).

Group	Value	95% CI
BI 1026706 - Tablet 25 mg (SRD - Part)	3.02	± 21.1
BI 1026706 - Tablet 50 mg (SRD - Part)	2.75	± 51.2
BI 1026706 - Tablet 100 mg (SRD - Part)	3.43	± 33.4
BI 1026706 - Tablet 200 mg (SRD - Part)	1.95	± 27.2
BI 1026706 - Tablet 400 mg (SRD - Part)	1.87	± 45.3
BI 1026706 - Solution 10 mg (SRD - Part)	3.97	± 40.8
BI 1026706 - Solution 100 mg (SRD - Part)	3.47	± 23.9
BI 1026706 - Solution 200 mg (SRD - Part)	3.82	± 32.8
BI 1026706 - Solution 400 mg (SRD - Part)	2.09	± 7.44

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BI 1026706 - Tablet 25 mg (SRD - Part)

Serious: 0/6 (0%)

Deaths: —

BI 1026706 - Tablet 50 mg (SRD - Part)

Serious: 0/6 (0%)

Deaths: —

BI 1026706 - Tablet 100 mg (SRD - Part)

Serious: 0/6 (0%)

Deaths: —

BI 1026706 - Tablet 200 mg (SRD - Part)

Serious: 0/6 (0%)

Deaths: —

BI 1026706 - Tablet 400 mg (SRD - Part)

Serious: 0/4 (0%)

Deaths: —

BI 1026706 - Solution 10 mg (SRD - Part)

Serious: 0/6 (0%)

Deaths: —

BI 1026706 - Solution 100 mg (SRD - Part)

Serious: 0/5 (0%)

Deaths: —

BI 1026706 - Solution 200 mg (SRD - Part)

Serious: 0/6 (0%)

Deaths: —

BI 1026706 - Solution 400 mg (SRD - Part)

Serious: 0/5 (0%)

Deaths: —

Placebo (SRD - Part)

Serious: 0/18 (0%)

Deaths: —

BI 1026706 - Solution 100 mg Fasted (R2)

Serious: 0/11 (0%)

Deaths: —

BI 1026706 - 100 mg Solution Fed (T2)

Serious: 0/12 (0%)

Deaths: —

BI 1026706 - Tablet 100 mg Fasted (R1)

Serious: 0/12 (0%)

Deaths: —

BI 1026706 - Tablet 100 mg Fed (T1)

Serious: 0/10 (0%)

Deaths: —

Other adverse events (30 terms — click to expand)

Reaction	System	BI 1026706 - Tablet 25 mg …	BI 1026706 - Tablet 50 mg …	BI 1026706 - Tablet 100 mg…	BI 1026706 - Tablet 200 mg…	BI 1026706 - Tablet 400 mg…	BI 1026706 - Solution 10 m…	BI 1026706 - Solution 100 …	BI 1026706 - Solution 200 …	BI 1026706 - Solution 400 …	Placebo (SRD - Part)	BI 1026706 - Solution 100 …	BI 1026706 - 100 mg Soluti…	BI 1026706 - Tablet 100 mg…	BI 1026706 - Tablet 100 mg…
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Skin irritation	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Ear discomfort	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Ear pain	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Haematochezia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Application site haematoma	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oral herpes	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Laceration	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Heart rate increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Platelet count increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tendon pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Presyncope	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dysuria	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dry throat	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT01763333 adverse events section.

Sponsor's own description

To investigate the safety, tolerability, pharmacokinetics and the relative bioavailability of BI 1026706

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of BI 1026706

Trials testing the same drug.

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Other Boehringer Ingelheim trials

Trials by the same sponsor.

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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 NCT01763333 (US National Library of Medicine, public domain)
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/NCT01763333.

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

NCT01763333

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 Healthy

Other Boehringer Ingelheim trials

Verify against primary sources