NCT02974361

Brief Summary

This study is to help development of a new version of Ibuprofen, called Ibuprofen-LDH. Ibuprofen-LDH will be used as a treatment for muscular pains, headache, fever etc. This new version of ibuprofen is expected to produce fewer stomach/intestine related side effects when compared to many existing marketed formulations of Ibuprofen. This study is split into 3 parts. Part A is a 7 way crossover, Part B is a maximum of a 6 way crossover and Part C is a maximum of a 4 way crossover. The size of Parts B \& Part C and allocated interventions will be confirmed after review of data from Parts A and/or B respectively. A total of 30 subjects will take part in the study; 10 per study part. The key objective is to assess the pharmacokinetics properties of Ibuprofen-LDH, with and without a selection of different excipients. The pharmacokinetic properties will include how quickly the drug is absorbed into the bloodstream and also the maximum concentration of drug that reaches the bloodstream.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 28, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2017

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2017

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

November 21, 2016

Last Update Submit

May 2, 2017

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • Cmax

    12 hours

  • AUC(0-inf)

    12 hours

Study Arms (17)

Part A Ibuprofen control

ACTIVE COMPARATOR
Drug: Ibuprofen

Part A Ibuprofen-LDH

EXPERIMENTAL
Drug: Ibuprofen-LDH

Part A Ibuprofen-LDH Excipient Combo 1

EXPERIMENTAL
Drug: Ibuprofen-LDH

Part A Ibuprofen-LDH Excipient Combo 2

EXPERIMENTAL
Drug: Ibuprofen-LDH

Part A Ibuprofen-LDH Excipient Combo 3

EXPERIMENTAL
Drug: Ibuprofen-LDH

Part A Ibuprofen-LDH Excipient Combo 4

EXPERIMENTAL
Drug: Ibuprofen-LDH

Part A Ibuprofen Lysine

ACTIVE COMPARATOR
Drug: Ibuprofen Lysine

Part B Ibuprofen

ACTIVE COMPARATOR
Drug: Ibuprofen

Part B Ibuprofen LDH Excipient Combo 1

EXPERIMENTAL
Drug: Ibuprofen-LDH

Part B Ibuprofen LDH Excipient Combo 2

EXPERIMENTAL
Drug: Ibuprofen-LDH

Part B Ibuprofen LDH Excipient Combo 3

EXPERIMENTAL
Drug: Ibuprofen-LDH

Part B Ibuprofen LDH Excipient Combo 4

EXPERIMENTAL
Drug: Ibuprofen-LDH

Part C Ibuprofen

ACTIVE COMPARATOR
Drug: Ibuprofen

Part C Ibuprofen LDH Excipient Combo 1

EXPERIMENTAL
Drug: Ibuprofen-LDH

Part C Ibuprofen LDH Excipient Combo 2

EXPERIMENTAL
Drug: Ibuprofen-LDH

Part C Ibuprofen LDH Excipient Combo 3

EXPERIMENTAL
Drug: Ibuprofen-LDH

Part B Ibuprofen LDH Excipient Combo 5

EXPERIMENTAL
Drug: Ibuprofen-LDH

Interventions

IbuprofenDRUG
Part A Ibuprofen controlPart B IbuprofenPart C Ibuprofen
Ibuprofen LysineDRUG
Part A Ibuprofen Lysine
Ibuprofen-LDHDRUG
Part A Ibuprofen-LDHPart A Ibuprofen-LDH Excipient Combo 1Part A Ibuprofen-LDH Excipient Combo 2Part A Ibuprofen-LDH Excipient Combo 3Part A Ibuprofen-LDH Excipient Combo 4Part B Ibuprofen LDH Excipient Combo 1Part B Ibuprofen LDH Excipient Combo 2Part B Ibuprofen LDH Excipient Combo 3Part B Ibuprofen LDH Excipient Combo 4Part B Ibuprofen LDH Excipient Combo 5Part C Ibuprofen LDH Excipient Combo 1Part C Ibuprofen LDH Excipient Combo 2Part C Ibuprofen LDH Excipient Combo 3

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female subjects
  • BMI 18 - 30 kg/m2
  • Willing and able to provide written informed consent

You may not qualify if:

  • Evidence or history of significant renal, hepatic, gastrointestinal, central nervous system, respiratory, cardiovascular, autoimmune or metabolic dysfunction
  • Recent or concurrent use of prescription or non-prescription medications, other than contraceptives
  • Allergy or sensitivity to NSAIDs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simbec Orion Ltd

Merthyr Tydfil, CF48 4DR, United Kingdom

Location

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Annelize Koch

    Simbec Orion Ltd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2016

First Posted

November 28, 2016

Study Start

December 1, 2016

Primary Completion

April 28, 2017

Study Completion

May 3, 2017

Last Updated

May 3, 2017

Record last verified: 2017-05

Locations

GB(1)