SMP-028/midazolam drug: drug interaction study

ISRCTN	ISRCTN47498012
DOI	https://doi.org/10.1186/ISRCTN47498012
Protocol serial number	D4050157
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: 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

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 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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	SMP-028, midazolam
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/07/2010

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	24
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

United Kingdom
England

Study participating centre

Dainippon Sumitomo Pharma Europe Ltd

London
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?
HRA research summary			28/06/2023	No	No
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

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