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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1026706 Placebo; Drug: BI 1026706

• Registration Number: NCT01763333
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-07
• Study First Submitted QC: 2013-01-07
• Study Start: 2013-01-08
• Study First Posted: 2013-01-08
• Primary Completion: 2013-09-04
• Study Completion: 2013-09-04
• Status Verified: 2018-12
• Results First Submitted: 2018-12-14
• Results First Submitted QC: 2018-12-14
• Last Update Submitted: 2018-12-14
• Results First Posted: 2019-03-25
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1 BI 1026706 single rising dose part	BI 1026706 Placebo	single rising doses of BI 1026706
1 BI 1026706 single rising dose part	BI 1026706	single rising doses of BI 1026706
2 BI 1026706 bioavailability part	BI 1026706	bioavailability part of BI 1026706

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Drug Related Adverse Events	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.

Secondary Outcome Measures

Name	Time	Method
Cmax	-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 median tmax and without important protocol violations (PVs) relevant to the statistical evaluation of pharmacokinetic (PK). The same definition applies for the analysis set PPS-BA-T2-R2, PPS-BA-R2-R1 and PPS-BA-T2-T1.
Tmax (Time From Dosing to Maximum Measured Concentration)	-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).
AUC0-inf	-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).
AUC0- tz	-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).
t1/2 (Terminal Half-life of the Analyte in Plasma)	-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).
f t1-t2 (SRD-Part)	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).

Trial Locations

Locations (1)

1320.1.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Ingelheim, Germany