ISRCTN ISRCTN47498012
DOI https://doi.org/10.1186/ISRCTN47498012
Secondary identifying numbers D4050157
Submission date
19/03/2010
Registration date
15/04/2010
Last edited
02/08/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Noreen O'Connor
Scientific

Dainippon Sumitomo Pharma Europe Ltd
1st Floor, Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom

Study information

Study designRandomised open-label two-period crossover study in healthy subjects
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format. Please use the contact details below to request a subject information sheet.
Scientific titleAn exploratory, randomised, open-label, two-period, crossover study in healthy subjects to evaluate the effect of SMP-028 on the pharmacokinetics of midazolam
Study objectives1. Primary:
To assess the effect of repeat dose administration of SMP-028 on the single-dose pharmacokinetic (PK) profile of the CYP3A4 substrate, midazolam, in healthy subjects
2. Secondary:
2.1. To assess the safety and tolerability of SMP-028
2.2. To assess the safety and tolerability of the co-administration of SMP-028 and the CYP3A4 substrate midazolam
Ethics approval(s)Capenhurst Independent Research Ethics Committee, 16/03/2010, ref: 10/IEC01/4 [D4050157]
Health condition(s) or problem(s) studiedAsthma
InterventionSubjects 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 oral SMP-028 200 mg once daily in the morning on Days 1 to 5. Single dose of midazolam 7.5 mg orally on the morning of Day 5.
Treatment B consists of a single dose of midazolam 7.5 mg orally on Day 1.
Subjects will be followed up for 7 days in Treatment A and 3 days in Treatment B.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)SMP-028, midazolam
Primary outcome measurePharmacokinetics:
1. Primary endpoints:
Comparative midazolam exposure between treatment periods (AUC[0-∞] and C[max]) over 24 hours
2. Secondary endpoints:
Comparative midazolam exposure between treatment periods (other pharmacokinetic parameters), and exposure levels of the active metabolite α-hydroxymidazolam over 24 hours.
Secondary outcome measures2. Safety:
2.1. The proportion of subjects with adverse events (AEs)
2.2. Changes in standard laboratory safety tests:
2.2.1. Haematology
2.2.2. Clinical chemistry
2.2.3. Urinalysis
2.3. Concomitant medication review
2.4. Vital signs
2.5. Complete physical examinations
2.6. 12-lead ECG
Overall study start date20/05/2010
Completion date31/07/2010

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants24 healthy subjects (12 in each group). In order to obtain 24 completers, it is estimated that 26 subjects will be enrolled.
Key inclusion criteriaHealthy 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
Key exclusion criteriaStandard exclusion criteria for a healthy volunteer study
Date of first enrolment20/05/2010
Date of final enrolment31/07/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Dainippon Sumitomo Pharma Europe Ltd
London
SW1E 6QT
United Kingdom

Sponsor information

Dainippon Sumitomo Pharma Europe Ltd (UK)
Industry

c/o Dr Noreen O'Connor
1st Floor, Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom

Website http://www.ds-pharma.co.jp/english
ROR logo "ROR" https://ror.org/03sh4z743

Funders

Funder type

Industry

Dainippon Sumitomo Pharma Co. Ltd (Japan)
Private sector organisation / For-profit companies (industry)
Alternative name(s)
Dainippon Sumitomo Pharma Co., Ltd.
Location
Japan

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

02/08/2016: No publications found, verifying study status with principal investigator.