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

NCT02521207 | Completed Phase 1

• 1 other identifier: OXP001-003
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastroduodenal Erosions

Outcome Measures

Primary Outcomes (4)

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

  Part 1; Day 1 and Day 4

• Part 2: Comparison of Average Lanza Score

  Part 2; Day 8

• Part 2: Comparison of Average Number of Erosions

  Day 8

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

  Part 1; Day 1 and Day 4

Study Arms (4)

Part 1 OXP001

EXPERIMENTAL

OXP001 formulation containing 800mg ibuprofen single dose

Drug: Ibuprofen

Part 1 Ibuprofen control

ACTIVE COMPARATOR

Ibuprofen control 800mg single dose

Drug: Ibuprofen

Part 2 OXP001

EXPERIMENTAL

OXP001 formulation containing 800mg ibuprofen three times per day

Drug: Ibuprofen

Part 2 Ibuprofen control

EXPERIMENTAL

Ibuprofen control 800mg three times per day

Drug: Ibuprofen

Interventions

Ibuprofen DRUG

Part 1 Ibuprofen control; Part 1 OXP001; Part 2 Ibuprofen control; Part 2 OXP001

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxford Pharmascience Ltd: lead
• Quotient Clinical: collaborator

Study Sites (1)

Quotient Clinical Ltd

Nottingham, Notts, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Stuart Mair

  Quotient Clinical Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 13, 2015
• Study Start: July 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 28, 2015

Record last verified: 2015-10

Locations

GB (1)