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A Four-Part Study to Assess the Safety, Tolerability, PK and PD of ONO-5788 in Healthy Adult Volunteers

NCT03571594 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2019-06-05

No results posted yet for this study

Summary

This is a first in human study to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ONO-5788 in healthy adult volunteers. This study will be conducted in 4 parts: a single-ascending dose part, a multiple-ascending dose part, an elderly part and a proof of principle part.

Conditions

Interventions

DRUG

ONO-5788

Investigational drug

DRUG

ONO-5788 Placebo

Placebo Comparator

DRUG

Octreotide

Active Comparator in Part D

Sponsors & Collaborators

  • Ono Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Terry O'Reilly, MD · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-07
Primary Completion
2019-05-16
Completion
2019-05-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03571594 on ClinicalTrials.gov