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Bioavailability Study With GLPG1972

NCT02851485 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-10-04

No results posted yet for this study

Summary

This is an open-label study to determine the pharmacokinetics of a new tablet formulation of GLPG1972 and to compare it with this of the liquid solution used during the First-in-Human study (GLPG1972-CL-101). The impact of food intake on the oral bioavailability of GLPG1972 administered as tablet will also be investigated in this study. A dose of 600 mg has been selected. The study is a phase I randomized open-label cross-over study with three single dose treatments:

A) 600 mg GLPG1972 oral solution after overnight fast,

B) 600 mg GLPG1972 oral tablet after overnight fast,

C) 600 mg GLPG1972 oral tablet 30 minutes after high-fat high-calorie breakfast.

A washout of at least 6 days between subsequent dosing days is respected so that no measurable plasma levels or biologically significant effects are remaining. There will be frequent assessment of adverse experiences post-dose. Twelve healthy male subjects will be selected according to the inclusion and exclusion criteria and 2 subjects each will be randomized to one of the 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA)

Conditions

Interventions

DRUG

GLPG1972 600 mg oral solution fasted

dosing after overnight fasting

DRUG

GLPG1972 600 mg oral tablet fasted

dosing after overnight fasting

DRUG

GLPG1972 600 mg oral tablet fed

dosing after high-fat high-calorie breakfast

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Ennis Lee, MD · Galapagos NV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2016-07-31
Completion
2016-08-31

Countries

  • Netherlands

Study Locations

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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 NCT02851485 on ClinicalTrials.gov