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A 5-Period, Single Dose, Phase 1 Study in Healthy Elderly Subjects to Assess Relative Bioavailability and Food Effect of Two Oral Formulations of GSK1325756 (Free Base vs HBr Salt) and Food Effect on the HBr Formulation When Given With Omeprazole

NCT02453022 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-07-24

No results posted yet for this study

Summary

The current study will help to increase our understanding of the pharmacokinetics (PK) of danirixin. The primary objective of the study is to estimate the relative bioavailability of danirixin Hydrobromide (HBr) tablet, when compared to danirixin free base (FB). Safety and tolerability information for oral administration of danrixin HBr tablets in elderly subjects will also be obtained. Secondarily, this study will evaluate effect of food on PK of danirixin HBr, effect of gastric acid suppression, and within-subject PK variability of danirixin HBr. The outcome of this study will contribute to the selection of the most appropriate formulation/dosing regimen for future studies.

This is an open-label, 5-period crossover study. Study will be conducted in 18 healthy elderly subjects. Screening will occur within 42 days prior to Day 1 of period 1. The Treatment Periods will be separated by a washout period of a minimum 5 days. Follow-up will be done within 3 to 10 days post last dose.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Danirixin HBr 50 mg IR Tablet

Danirixin HBr 50 mg IR Tablet is white, film-coated, oval-shaped tablet for oral administration.

DRUG

Danirixin FB 50 mg IR Tablet

Danirixin FB 50 mg IR Tablet is white, film-coated, capsule-shaped tablet for oral administration.

DRUG

Prilosec (omeprazole) 40mg Delayed-Release capsule

Prilosec (omeprazole) 40 mg delayed-release capsule is opaque, hard gelatin, apricot, and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body for oral administration.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-18
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

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Entities

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 NCT02453022 on ClinicalTrials.gov