Condition category
Respiratory
Date applied
19/03/2010
Date assigned
15/04/2010
Last edited
02/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ds-pharma.co.jp/english

Contact information

Type

Scientific

Primary contact

Dr Noreen O'Connor

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

D4050157

Study information

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

Acronym

Study hypothesis

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

Capenhurst Independent Research Ethics Committee, 16/03/2010, ref: 10/IEC01/4 [D4050157]

Study design

Randomised open-label two-period crossover study in healthy subjects

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format. Please use the contact details below to request a subject information sheet.

Condition

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 names

SMP-028, midazolam

Primary outcome measures

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 trial start date

20/05/2010

Overall trial end date

31/07/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Healthy volunteer

Age group

Adult

Gender

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.

Participant exclusion criteria

Standard exclusion criteria for a healthy volunteer study

Recruitment start date

20/05/2010

Recruitment end date

31/07/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dainippon Sumitomo Pharma Europe Ltd
London
SW1E 6QT
United Kingdom

Sponsor information

Organisation

Dainippon Sumitomo Pharma Europe Ltd (UK)

Sponsor details

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

Sponsor type

Industry

Website

http://www.ds-pharma.co.jp/english

Funders

Funder type

Industry

Funder name

Dainippon Sumitomo Pharma Co. Ltd (Japan)

Alternative name(s)

Dainippon Sumitomo Pharma Co., Ltd.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Japan

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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