SMP-028/ketoconazole drug: drug interaction study
| ISRCTN | ISRCTN41050179 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41050179 |
| Protocol serial number | D4050156 |
| Sponsor | Dainippon Sumitomo Pharma Europe Ltd (UK) |
| Funder | Dainippon Sumitomo Pharma Co. Ltd (Japan) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Dainippon Sumitomo Pharma Europe Ltd
1st Floor, Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised open-label two-period crossover study in healthy subjects |
| Secondary study design | Randomised cross over trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ketoconazole, SMP-028 |
| Primary outcome measure(s) |
Pharmacokinetics: |
| Key secondary outcome measure(s) |
Safety endpoints: |
| Completion date | 30/06/2010 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 32 |
| 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
- United Kingdom
- England
Study participating centre
SW1E 6QT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/07/2016: No publications found, verifying study status with principal investigator.
