SMP-028/midazolam drug: drug interaction study
ISRCTN | ISRCTN47498012 |
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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
Contact information
Dr Noreen O'Connor
Scientific
Scientific
Dainippon Sumitomo Pharma Europe Ltd
1st Floor, Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom
Study information
Study design | Randomised open-label two-period crossover study in healthy subjects |
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Primary study design | Interventional |
Secondary study design | Randomised cross over trial |
Study setting(s) | Other |
Study type | Treatment |
Participant information sheet | Not available in web format. Please use the contact details below to request a subject information sheet. |
Scientific title | An exploratory, randomised, open-label, two-period, crossover study in healthy subjects to evaluate the effect of SMP-028 on the pharmacokinetics of midazolam |
Study objectives | 1. 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) studied | 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 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 type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | SMP-028, midazolam |
Primary outcome measure | Pharmacokinetics: 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 measures | 2. 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 date | 20/05/2010 |
Completion date | 31/07/2010 |
Eligibility
Participant type(s) | Healthy volunteer |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 24 healthy subjects (12 in each group). In order to obtain 24 completers, it is estimated that 26 subjects will be enrolled. |
Key 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 |
Key exclusion criteria | Standard exclusion criteria for a healthy volunteer study |
Date of first enrolment | 20/05/2010 |
Date of final enrolment | 31/07/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Dainippon Sumitomo Pharma Europe Ltd
London
SW1E 6QT
United Kingdom
SW1E 6QT
United Kingdom
Sponsor information
Dainippon Sumitomo Pharma Europe Ltd (UK)
Industry
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 |
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https://ror.org/03sh4z743 |
Funders
Funder type
Industry
Dainippon Sumitomo Pharma Co. Ltd (Japan)
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Dainippon Sumitomo Pharma Co., Ltd.
- Location
- Japan
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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.