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Safety, Tolerability and Pharmacokinetics of BI 653048 H3PO4 Oral Drinking Solution in Healthy Male Volunteers

NCT02217644 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-08-15

No results posted yet for this study

Summary

* Investigation of safety and tolerability of BI 653048 H3PO4 following the administration of single rising doses of an aqueous solution in healthy male subjects
* Pharmacokinetic and pharmacodynamic characteristics of BI 653048, including the investigation of dose proportionality
* Investigation of relative bioavailability of capsules versus aqueous solution

Conditions

  • Healthy

Interventions

DRUG

BI 653048 H3PO4 solution

DRUG

BI 653048 H3PO4 low dose capsule

DRUG

BI 653048 H3PO4 high dose capsule

DRUG

Placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-06-30

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02217644 on ClinicalTrials.gov