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

• ClinicalTrials.gov Identifier: NCT01958060
• Recruitment Status: Terminated
• First Posted: October 8, 2013
• Results First Posted: July 30, 2015
• Last Update Posted: July 30, 2015
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Study Description

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

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: BI 1034020; Drug: Placebo to BI 1034020	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Intravenous and Subcutaneous Doses of BI 1034020 in Healthy Male Volunteers (Partially Randomised, Single-blind, Placebo-controlled Within Dose Groups, Clinical Phase I Study)
• Study Start Date: October 2013
• Actual Primary Completion Date: April 2014
• Actual Study Completion Date: April 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: BI 1034020 intravenous part; single rising doses	Drug: BI 1034020; intravenous part; Drug: Placebo to BI 1034020; intravenous part
Experimental: BI 1034020 subcutaneous part; single rising doses	Drug: BI 1034020; intravenous part; Drug: Placebo to BI 1034020; intravenous part

Outcome Measures

Primary Outcome Measures :

1. Percentage of Subjects With Drug Related Adverse Events [ Time Frame: 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 :

1. Cmax [ Time Frame: 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).
2. AUC0-inf [ Time Frame: 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.

3. AUC0-tz [ Time Frame: 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 ).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion criteria:

1. Healthy males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
2. Age within the range of 18 to 40 years
3. Body mass index within the range of 18.5 and 29.9 kg/m2
4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.

Exclusion criteria:

1. Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator. Pulse rate outside the range of 50-90 bpm or blood pressure outside the ranges of 90-140 for systolic and 50-90 mmHg for diastolic blood pressure if confirmed by repeat measurement
2. Any evidence of a clinically relevant concomitant disease.
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
4. Surgery of the gastrointestinal tract (except appendectomy).
5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.
6. History of relevant orthostatic hypotension, fainting spells or blackouts.
7. Chronic or relevant acute infections.

Contacts and Locations

Locations

Germany

1312.1.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

1312.1.2 Boehringer Ingelheim Investigational Site

Ingelheim, Germany

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim; Boehringer Ingelheim

More Information

Additional Information:

Related Info 

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT01958060
• Other Study ID Numbers: 1312.1; 2011-004615-23 ( EudraCT Number: EudraCT )
• First Posted: October 8, 2013
• Results First Posted: July 30, 2015
• Last Update Posted: July 30, 2015
• Last Verified: July 2015