SMP-028/ketoconazole drug: drug interaction study
| ISRCTN | ISRCTN41050179 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41050179 |
| Secondary identifying numbers | D4050156 |
- Submission date
- 19/03/2010
- Registration date
- 15/04/2010
- Last edited
- 11/07/2016
- 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 |
|---|---|
| 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 ketoconazole on the pharmacokinetics of SMP-028 |
| Study objectives | 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(s) | Capenhurst Independent Research Ethics Committee, 16/03/2010 |
| 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 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ketoconazole, SMP-028 |
| Primary outcome measure | 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 study start date | 18/03/2010 |
| Completion date | 30/06/2010 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | 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. |
| 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 | 18/03/2010 |
| Date of final enrolment | 30/06/2010 |
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 Noreen O'Connor, PhD
1st Floor, Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom
| Website | http://www.ds-pharma.co.jp/english |
|---|---|
"ROR" |
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 | |
|---|---|
| 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 |
Editorial Notes
11/07/2016: No publications found, verifying study status with principal investigator.
