Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of Single Escalating Doses of BI 1034020 Administered Intravenously or Subcutaneously to Male Healthy Volunteers

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: BI 1034020; Drug: Placebo to BI 1034020

• Registration Number: NCT01958060
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Investigation of safety and tolerability of BI 1034020 in healthy male volunteers following intravenous (IV) infusion of subcutaneous (SC) injection of single doses and exploration of the pharmacokinetics and pharmacodynamics of BI 1034020 after single dosing and determination of the bioavailability of subcutaneous injections of BI 1034020

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-01
• Study First Submitted QC: 2013-10-01
• Study First Posted: 2013-10-08
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-07
• Results First Submitted: 2015-07-02
• Results First Submitted QC: 2015-07-02
• Last Update Submitted: 2015-07-02
• Results First Posted: 2015-07-30
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 35

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
BI 1034020 intravenous part	Placebo to BI 1034020	single rising doses
BI 1034020 intravenous part	BI 1034020	single rising doses
BI 1034020 subcutaneous part	Placebo to BI 1034020	single rising doses
BI 1034020 subcutaneous part	BI 1034020	single rising doses

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Drug Related Adverse Events	from the first drug administration to end of trial, up to 50 days	Percentage of subjects with investigator defined drug-related adverse events

Secondary Outcome Measures

Name	Time	Method
Cmax	2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.	Maximum measured concentration of BI 1034020 in plasma (Cmax).
AUC0-inf	2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).; AUC0-inf could be assessed only in 50 mg iv dose group as terminal phase was below lower limit of quantification (BLQ) for other dose groups. Therefore dose proportionality for AUC0-inf could not be performed in this trial.
AUC0-tz	2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.	Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose (AUC0-tz ).

Trial Locations

Locations (2)

1312.1.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany

1312.1.2 Boehringer Ingelheim Investigational Site; 🇩🇪 Ingelheim, Germany