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

Gastroduodenal Erosions Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02521207
• Other study ID #: OXP001-003
• Status: Completed
• Phase: Phase 1
• First received: August 5, 2015
• Last updated: October 27, 2015
• Start date: July 2015
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Oxford Pharmascience Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastroduodenal Erosions

Intervention

Drug:
• Ibuprofen

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical Ltd	Nottingham	Notts

Sponsors (2)

Lead Sponsor	Collaborator
Oxford Pharmascience Ltd	Quotient Clinical

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Comparison of Peak Plasma Concentration (Cmax)		Part 1; Day 1 and Day 4	No
Primary	Part 2: Comparison of Average Lanza Score		Part 2; Day 8	Yes
Primary	Part 2: Comparison of Average Number of Erosions		Day 8	Yes
Primary	Part 1: Comparison of Area Under the Curve (AUC)		Part 1; Day 1 and Day 4	No