Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
D4050156
Study information
Scientific title
An exploratory, randomised, open-label, two-period, crossover study in healthy subjects to evaluate the effect of ketoconazole on the pharmacokinetics of SMP-028
Acronym
Study hypothesis
Primary aim:
To assess the effects of administration of the CYP3A4 inhibitor, ketoconazole, on the single dose pharmacokinetic (PK) profile of SMP-028 in healthy subjects.
Secondary aim:
To assess the safety and tolerability of SMP-028 when co-administered with the CYP3A4 inhibitor, ketoconazole.
Ethics approval
Capenhurst Independent Research Ethics Committee, 16/03/2010
Study design
Randomised open-label two-period crossover study in healthy subjects
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format. Please use the contact details below to request a subject information sheet
Condition
Asthma
Intervention
Subjects will be randomised (in a 1:1 ratio) into one of two treatment sequences (Treatment A followed by Treatment B or Treatment B followed by Treatment A):
Treatment A consists of Ketoconazole 400 mg daily, administered orally twice a day on Days 1 to 7 followed by a single oral dose of SMP-028 20 mg on the morning of Day 5.
Treatment B consists of a single dose of SMP-028 20 mg on Day 1.
Subjects will be followed up for 8 days after dosing in Treatment A and 4 days in Treatment B.
Intervention type
Drug
Phase
Not Applicable
Drug names
Ketoconazole, SMP-028
Primary outcome measures
Pharmacokinetics:
1. Primary endpoints:
Comparative SMP-028 exposure between treatment periods (AUC[0-∞] and C[max]) over 72 hours
2. Secondary endpoints:
Comparative SMP-028 exposure between treatment periods (other pharmacokinetic parameters), and exposure levels of the metabolites of SMP-028 over 72 hours
Secondary outcome measures
Safety endpoints:
1. The proportion of subjects with adverse events (AEs)
2. Changes in standard laboratory safety tests
2.1. haematology
2.2. clinical chemistry
2.3. urinalysis
3. Concomitant medication review
4. Vital signs
5. Complete physical examinations
6. 12-lead ECG
Overall trial start date
18/03/2010
Overall trial end date
30/06/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Healthy subjects aged 18 to 55 years who are in good health as determined by past medical history, physical examination, electrocardiogram, clinical safety laboratory tests and urinalysis
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
32 healthy subjects (16 in each group). In order to obtain 32 completers, it is estimated that 34 subjects will be enrolled.
Participant exclusion criteria
Standard exclusion criteria for a healthy volunteer study
Recruitment start date
18/03/2010
Recruitment end date
30/06/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dainippon Sumitomo Pharma Europe Ltd
London
SW1E 6QT
United Kingdom
Sponsor information
Organisation
Dainippon Sumitomo Pharma Europe Ltd (UK)
Sponsor details
c/o Noreen O'Connor
PhD
1st Floor
Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Dainippon Sumitomo Pharma Co. Ltd (Japan)
Alternative name(s)
Dainippon Sumitomo Pharma Co., Ltd.
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
Japan
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary