NCT01841112 is a Phase 1 clinical trial of BI-409306 25 milligram (mg) SD in Healthy, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT01841112?

NCT01841112 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT01841112?

Interventions in NCT01841112: Placebo, BI-409306 25 milligram (mg) SD, BI-409306 50 mg SD, BI-409306 100 mg SD, BI-409306 100 mg MD.

Is NCT01841112 still recruiting?

NCT01841112 is currently completed. Last updated 25 June 2024.

Are results published for NCT01841112?

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

Last reviewed 2024-06-25 · How we verify

NCT01841112

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

Safety, Tolerability and Pharmacokinetics of BI 409306 Tablets in Healthy Asian Male Volunteers

Completed Phase 1 Results posted Last updated 25 June 2024

What this trial tests

Phase 1 trial testing Placebo in Healthy in 65 participants. Completed in 18 July 2013.

Timeline

22 April 2013

Primary endpoint
18 July 2013

18 July 2013

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	65
Start date	22 April 2013
Primary completion	18 July 2013
Estimated completion	18 July 2013
Sites	1 location across South Korea

Drugs / interventions tested

Placebo
BI-409306 25 milligram (mg) SD — full drug profile →
BI-409306 50 mg SD — full drug profile →
BI-409306 100 mg SD — full drug profile →
BI-409306 100 mg MD — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 20 to 45, 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.

Percentage (%) of Subjects With Drug-related Adverse Events (AEs) Primary · From first drug administration until 11 days after last dose of study medication, up to 18 days.

Percentage (%) of subjects with drug-related adverse events (AEs).

Group	Value	95% CI
Placebo	13.3
BI-409306 25 Milligram (mg) SD	9.1
BI-409306 50 mg SD	36.4
BI-409306 100 mg SD	57.9
BI-409306 100 mg MD-PM	83.3
BI-409306 100 mg SD-PM	83.3

Maximum Measured Concentration of a Single Dose of BI 409306 in Plasma (Cmax) Secondary · PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.

Maximum measured concentration of a single dose of BI 409306 in plasma (Cmax).

Group	Value	95% CI
BI-409306 25 mg - Chinese	292	± 113.0
BI-409306 50 mg - Chinese	824	± 74.1
BI-409306 100 mg - Chinese	1970	± 77.8
BI-409306 100 mg - Chinese (PM)	4020	± 26.8
BI-409306 25 mg - Japanese	496	± 26.5
BI-409306 50 mg - Japanese	914	± 32.5
BI-409306 100 mg - Japanese	3290	± 43.0
BI-409306 100 mg SD & MD - Japanese (PM)	4510	± 26.8

Area Under the Concentration-time Curve of a Single Dose of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) Secondary · PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.

Area under the concentration-time curve of a single dose of BI 409306 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity).

Group	Value	95% CI
BI-409306 25 mg - Chinese	376	± 67.7
BI-409306 50 mg - Chinese	1070	± 119.0
BI-409306 100 mg - Chinese	2020	± 106.0
BI-409306 100 mg - Chinese (PM)	7550	± 21.4
BI-409306 25 mg - Japanese	504	± 24.7
BI-409306 50 mg - Japanese	985	± 40.3
BI-409306 100 mg - Japanese	2100	± 47.1
BI-409306 100 mg SD & MD - Japanese (PM)	8650	± 32.1

Area Under the Concentration-time Curve of a Single Dose of BI 409306 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz) Secondary · PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.

Area under the concentration-time curve of a single dose of BI 409306 in plasma over the time interval 0 to the last quantifiable data point (AUC0-tz).

Group	Value	95% CI
BI-409306 25 mg - Chinese	375	± 67.8
BI-409306 50 mg - Chinese	1040	± 102.0
BI-409306 100 mg - Chinese	2020	± 106.0
BI-409306 100 mg - Chinese (PM)	7550	± 21.4
BI-409306 25 mg - Japanese	504	± 24.8
BI-409306 50 mg - Japanese	985	± 40.3
BI-409306 100 mg - Japanese	2100	± 47.1
BI-409306 100 mg SD & MD - Japanese (PM)	8640	± 32.1

Maximum Measured Concentration of the Metabolite CD 13896 in Plasma (Cmax) Secondary · PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.

Maximum measured concentration of the metabolite CD 13896 in plasma (Cmax) after single administration of BI 409306.

Group	Value	95% CI
BI-409306 100 mg - Chinese	926	± 30.9
BI-409306 100 mg - Japanese	1080	± 24.5

Maximum Measured Concentration of the Metabolite CD 14084 in Plasma (Cmax) Secondary · PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.

Maximum measured concentration of the metabolite CD 14084 in plasma (Cmax) after single administration of BI 409306.

Group	Value	95% CI
BI-409306 100 mg - Chinese	3800	± 21.8
BI-409306 100 mg - Japanese	4340	± 16.9

Area Under the Concentration-time Curve of the Metabolite CD 13896 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) Secondary · PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.

Area under the concentration-time curve of the metabolite CD 13896 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity) after single administration of BI 409306.

Group	Value	95% CI
BI-409306 100 mg - Chinese	1650	± 14.2
BI-409306 100 mg - Japanese	1520	± 15.6

Area Under the Concentration-time Curve of the Metabolite CD 14084 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) Secondary · PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.

Area under the concentration-time curve of the metabolite CD 14084 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity) after single administration of BI 409306.

Group	Value	95% CI
BI-409306 100 mg - Chinese	8670	± 10.8
BI-409306 100 mg - Japanese	9060	± 14.6

Area Under the Concentration-time Curve of the Metabolite CD 13896 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz). Secondary · PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.

Area under the concentration-time curve of the metabolite CD 13896 in plasma over the time interval 0 to the last quantifiable data point (AUC0-tz) after single administration of BI 409306.

Group	Value	95% CI
BI-409306 100 mg - Chinese	1650	± 14.2
BI-409306 100 mg - Japanese	1510	± 15.6

Area Under the Concentration-time Curve of the Metabolite CD 14084 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz). Secondary · PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.

Area under the concentration-time curve of the metabolite CD 14084 in plasma over the time interval 0 to the last quantifiable data point (AUC0-tz) after single administration of BI 409306.

Group	Value	95% CI
BI-409306 100 mg - Chinese	8670	± 10.8
BI-409306 100 mg - Japanese	9060	± 14.6

Adverse events — posted to ClinicalTrials.gov

Time frame: From first drug administration until 11 days after last dose of study medication, up to 18 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/15 (0%)

Deaths: —

BI-409306 25 Milligram (mg) SD

Serious: 0/11 (0%)

Deaths: —

BI-409306 50 mg SD

Serious: 0/11 (0%)

Deaths: —

BI-409306 100 mg SD

Serious: 0/19 (0%)

Deaths: —

BI-409306 100 mg SD-PM

Serious: 0/6 (0%)

Deaths: —

BI-409306 100 mg MD-PM

Serious: 0/6 (0%)

Deaths: —

Other adverse events (17 terms — click to expand)

Reaction	System	Placebo	BI-409306 25 Milligram (mg…	BI-409306 50 mg SD	BI-409306 100 mg SD	BI-409306 100 mg SD-PM	BI-409306 100 mg MD-PM
Photopsia	Eye disorders	—	—	—	—	—	—
Chromatopsia	Eye disorders	—	—	—	—	—	—
Photophobia	Eye disorders	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—	—	—
Asthenopia	Eye disorders	—	—	—	—	—	—
Eye pain	Eye disorders	—	—	—	—	—	—
Visual impairment	Eye disorders	—	—	—	—	—	—
Orthostatic hypotension	Vascular disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—
Epigastric discomfort	Gastrointestinal disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Chest discomfort	General disorders	—	—	—	—	—	—
Feeling hot	General disorders	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT01841112 adverse events section.

Sponsor's own description

Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 409306 tablets in healthy Chinese and Japanese male volunteers of a known genotype as specified in the study protocol.

Publications & conference data

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

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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 NCT01841112 (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 June 2024

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/NCT01841112.

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

NCT01841112

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 recruiting trials for Healthy

Other Boehringer Ingelheim trials

Verify against primary sources