NCT02004301

Brief Summary

This is a single-centre, open-label, non-randomised, two-arm study in 12 healthy male volunteers. This study is designed to correlate the gastrointestinal transit behaviour of delayed-release diclofenac potassium tablets with their pharmacokinetic (PK) absorption profiles. We will be looking at:

  1. 1.The behaviour of the tablets (when, where and how quickly they break up)
  2. 2.The gastric emptying time of the tablets (when they leave the stomach)
  3. 3.The gastrointestinal transit of the tablets (how long they take to travel through the gut)
  4. 4.Blood levels of the drug (diclofenac)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 pain

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_1 pain

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

December 2, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 10, 2014

Status Verified

April 1, 2014

Enrollment Period

2 months

First QC Date

December 2, 2013

Last Update Submit

April 9, 2014

Conditions

Pain

Keywords

Formulation behaviourDrug absorption profile

Outcome Measures

Primary Outcomes (1)

  • Scintigraphic analysis of time and site of onset and complete release of radiolabel

    15 hours

Secondary Outcomes (1)

  • Pharmacokinetic (PK) absorption profiles and parameters of diclofenac

    15 hours

Study Arms (2)

Radiolabelled T4 Tablet

EXPERIMENTAL

Single dose of delayed release diclofenac potassium (25 mg) tablet with time delay of 4 h radiolabelled with 4 MBq 99mTc

Drug: Radiolabelled T4 Tablet

Radiolabelled T6 Tablet

EXPERIMENTAL

Single dose of delayed release diclofenac potassium (25 mg) tablet with time delay of 6 h radiolabelled with 4 MBq 99mTc

Drug: Radiolabelled T6 Tablet

Interventions

Radiolabelled T4 TabletDRUG
Also known as: Delayed release diclofenac potassium tablet
Radiolabelled T4 Tablet
Radiolabelled T6 TabletDRUG
Also known as: Delayed release diclofenac potassium tablet
Radiolabelled T6 Tablet

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Male 18 to 45 years inclusive. BMI 18.0 to 29.9 kg/m2. Body weight ≥50 kg. Understands and is willing, able and likely to comply with all study procedures and restrictions. Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent.
  • Good general health with (in the opinion of the Investigator) no clinically significant and relevant abnormalities of medical history or physical examination.

You may not qualify if:

  • Current or recurrent disease that could affect the study conduct or laboratory assessments.
  • Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.
  • History of current or relevant previous non self-limiting gastrointestinal disorders, in particular, peptic ulcer disease and/or gastrointestinal bleeding.
  • History of hypersensitivity to aspirin or any other NSAID. Currently suffering from disease known to impact gastric emptying, e.g. migraine, insulin-dependent diabetes mellitus.
  • Laboratory screening results that suggest an abnormal liver and/or renal function.
  • Subject has a screening QTc value of greater than or equal to 450 msec or an ECG that is not suitable for QTc measurements.
  • The physician responsible considers the volunteer unfit for the study. Taken prescribed medication within 14 days prior to the first Assessment Visit which, in the opinion of the physician responsible, will interfere with the study procedures or compromise safety.
  • Taken over-the-counter (OTC) medication within 48 hours prior to the first Assessment Visit. Subjects may still be entered into the study if, in the opinion of the physician responsible, the medication will not interfere with the study procedures or compromise safety. The occasional use of paracetamol for pain relief (within its labelled dosage) is permitted but must not be taken within 48 hours of an Assessment Visit.
  • Recent history (within the last year) of alcohol or other substance abuse. Average weekly alcohol intake of greater than 21 units. Positive urine drugs of abuse test at screening. Note: At the discretion of the Investigator, the test may be repeated Positive breath alcohol test at screening. Recently discontinued smoking (less than 3 months). Currently a smoker or user of nicotine-containing products. Allergy to a drug, to any component of the dosage form or any other allergy. Vegetarian. Lactose intolerant. Allergy to any of the contents of the standard dinner.
  • Participation in another clinical study (inclusive of final post-study examination) or receipt of an investigational drug within the 12 weeks before first screening visit.
  • Previous participation in this study. Will result in a participation in more than four studies over a twelve month period.
  • An employee of the sponsor, client or study site or members of their immediate family.
  • Will exceed the limits of total radiation exposure allowed in any 12 month period (5 mSv), or will exceed 10 mSv over any three year period.
  • Intending to father a child in the 3 months following the study or are unwilling to abstain from sexual intercourse with pregnant or lactating women Unwilling to use a condom/spermicide in addition to having their female partner use another form of contraception such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation if the woman could become pregnant from the time of the first Assessment Visit until 3 months following the study.
  • Donated blood or experienced significant blood loss within 3 months of screening and for the duration of the study.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bio-Imaging Centre, Basement Medical Block, Within Glasgow Royal Infirmary, 84 Castle Street

Glasgow, G4 0SF, United Kingdom

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Howard NE Stevens, PhD

    BDD Pharma Ltd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman

Study Record Dates

First Submitted

December 2, 2013

First Posted

December 9, 2013

Study Start

January 1, 2014

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 10, 2014

Record last verified: 2014-04

Locations

GB(1)