Single Rising Dose Study of BI 655088 Administered Intravenously in Healthy Male Volunteers

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Boehringer Ingelheim

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: BI 655088
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02696616
2014-002413-29 (EudraCT Number)
1339.1

Details and patient eligibility

About

Investigation of safety and tolerability of BI 655088 following intravenous infusion of single rising doses and exploration of the pharmacokinetics and pharmacodynamics of BI 655088 after single dosing

Enrollment

47 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy male subjects
  • Age of 18 to 50 years
  • Body mass index (BMI) of 18.5 to 29.9 kg/m2
  • Additional inclusion criteria may apply

Exclusion criteria

  • Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged as clinically relevant by the investigator
  • Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg or diastolic blood pressure outside the range of 50 to 90 mmHg or pulse rate outside the range of 45 to 90 bpm
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Any evidence of a concomitant disease judged as clinically relevant by the investigator
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Diseases of the central nervous system (including but not limited to any kind of seizures and stroke), and other relevant neurological disorders or psychiatric disorders
  • Additional exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

47 participants in 2 patient groups, including a placebo group

BI 655088
Experimental group
Treatment:
Drug: BI 655088
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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