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OpenTrials
Completed

NCT Number: NCT02521207

Pilot Study of OXP001(2) and Brufen in Healthy Subjects

The study will compare the study drug to an already marketed formulation of prescription strength ibuprofen (Brufen® the reference product) by looking at how the drug is taken up by the body and also by performing a specialist procedure called an endoscopy (or more specifically, a gastroscopy). The safety and tolerability of the study drug will also be assessed.

The study will consist of 2 parts involving up to 54 healthy male and female subjects. Subjects will be randomly assigned to receive either the study drug or reference product. Part 1 will be a cross over study in which up to 10 subjects will receive a single dose of 800 mg study drug OXP001 or Brufen® on Day 1, then a single dose of 800 mg study drug OXP001 or Brufen® on Day 4. Part 1 will assess bioavailability and involve an interim decision on progression to Part 2. In Part 2, up to 44 subjects will receive a dose of 800 mg OXP001 or Brufen® three times daily for 7 days in order to assess pharmacokinetics and stomach irritation using endoscopy.

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Key information

Conditions

Gastroduodenal Erosions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical Ltd

Nottingham, Notts, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male or female subject
  • Healthy, normal upper GI tract as indicated by no ulcers or erosions at baseline, as assessed by the gastroenterologist conducting the endoscopy (ie Lanza score of 0 in both the stomach and duodenum) (Part 2 only)
  • H. pylori negative

Exclusion criteria

  • Clinically significant abnormal laboratory parameters
  • Any clinically significant diseases or conditions affecting the haematopoietic, cardiovascular, renal, hepatic, endocrine, pulmonary, central nervous, immunological, dermatological, GI or any other body system

Treatment and study plan

Ibuprofen

Drug

Primary outcomes

  1. Part 1: Comparison of Peak Plasma Concentration (Cmax)

    Time frame: Part 1; Day 1 and Day 4

  2. Part 2: Comparison of Average Lanza Score

    Time frame: Part 2; Day 8

  3. Part 2: Comparison of Average Number of Erosions

    Time frame: Day 8

  4. Part 1: Comparison of Area Under the Curve (AUC)

    Time frame: Part 1; Day 1 and Day 4

Sponsors and collaborators

Lead sponsor

Oxford Pharmascience Ltd

Industry

Collaborators

  • Quotient Clinical

Registry information

Official study title

A Two-Part, Randomised, Open-Label, Evaluator-Blinded, Multiple-Dose, Phase I Pilot Study With OXP001 Ibuprofen 400 mg Tablets and Brufen® 400 mg Tablets to Assess the Comparative Bioavailability (Part 1) and Effects on Gastroduodenal Irritation (Part 2) in Healthy Human Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 13, 2015
Registry last updated
Oct 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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