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First-time-in-man, to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP1.5375

NCT01965301 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2015-01-21

No results posted yet for this study

Summary

Phase I Single Ascending Dose (Part 1), phase IIa Proof Of Concept (Part 2)

Conditions

  • Healthy Male Volunteers

Interventions

DRUG

BP1.5375 suspension

single oral dose

DRUG

Diphenhydramine

single oral dose of Diphenhydramine 50mg

DRUG

Placebo

Single oral dose

Sponsors & Collaborators

Principal Investigators

  • van Gerven Joop, MD · Centre for Human Drug Research

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2014-10-31
Completion
2014-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
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 NCT01965301 on ClinicalTrials.gov