SMP-028/Oral Contraceptive Drug: Drug Interaction study

ISRCTN	ISRCTN93391015
DOI	https://doi.org/10.1186/ISRCTN93391015
Protocol serial number	D4050158
Sponsor	Dainippon Sumitomo Pharma Europe Ltd (UK)
Funder	Dainippon Sumitomo Pharma Co. Ltd (Japan)

Submission date: 04/01/2010
Registration date: 19/01/2010
Last edited: 21/05/2010

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 double-blind placebo-controlled two-sequence two-period crossover study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised, double-blind, placebo-controlled, two-sequence, two-period, crossover study to evaluate the effect of SMP-028 on oral contraceptive pharmacokinetics in healthy female subjects
Study acronym	OC-DDI
Study objectives	Primary: To evaluate the effect of co-administration of SMP-028 on the pharmacokinetic (PK) profile of Microgynon 30®. Secondary: 1. To evaluate the PK profile of SMP-028 in healthy female subjects taking Microgynon 30® 2. To evaluate the effect of co-administration of SMP-028 on the pharmacodynamic (PD) response to Microgynon 30® 3. To assess the safety and tolerability of co-administration of SMP-028 and Microgynon 30® in healthy female subjects
Ethics approval(s)	Added 21/05/10: The Independent Ethics Committee of the Foundation Evaluation of Ethics in Biomedical Research Assen approved on the 11th of January 2010 (ref: D4050158 [OC-DDI])
Health condition(s) or problem(s) studied	Asthma
Intervention	Subjects will receive Microgynon 30® (or another brand of the OC pill containing equivalent components) during a 2 cycle synchronisation period. Subjects will continue to receive Microgynon 30® on days 1 to 21 of both treatment periods. Subjects will also receive either SMP-028 (160 mg) once daily or matching placebo on Days 1 to 21 of each treatment period. Each subject will receive SMP-028 for one treatment period, placebo for the other treatment period.
Intervention type	Drug
Phase	Phase I
Drug / device / biological / vaccine name(s)	SMP-028, Microgynon 30®
Primary outcome measure(s)	1. Pharmacokinetics: Drug exposure of the components of Microgynon 30® (ethinylestradiol [EE] and levonorgestrel [LNG]) as measured by serum AUC0-tlast and Cmax of EE and LNG on day 21 2. Pharmcodynamics: 2.1. Clotting times (e.g. prothrombin and activated partial thromboplastin times) measured at day 21 2.2. Maximum follicular diameter at day 21 2.3. Serum oestradiol, FSH, LH and progesterone levels taken at day 14 and 21 2.4. Sex hormone binding globulin (SHBG) at day 21
Key secondary outcome measure(s)	1. Pharmacokinetics: 1.1. Drug exposure of SMP-028 as measured by serum AUC0-tlast, and Cmax on day 21 1.2. Other PK parameters including Tmax, AUC0-8, λZ, t1/2, MRT, CL/F and Vz/F for SMP-028, EE and LNG on day 21 2. Safety endpoints: 2.1. Incidence and severity of adverse events (AEs) 2.2. Discontinuations due to AEs 2.3. Actual values and changes in values from baseline in standard laboratory safety tests, vital signs, physical examinations and 12-lead ECGs (electrocardiograms) Subjects will be provided with subject diary to record timing of OC intake and details of vaginal bleeding.
Completion date	30/06/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	22
Key inclusion criteria	1. Healthy female subjects aged 18 to 45 years 2. In good health as determined by: 2.1. Past medical history 2.2. Physical examination 2.3. Electrocardiogram 2.4. Clinical safety laboratory tests 2.5. Urinalysis
Key exclusion criteria	1. Contraindications to the administration of a combined oral contraceptive (OC) pill 2. Other standard exclusion criteria
Date of first enrolment	14/01/2010
Date of final enrolment	30/06/2010

Locations

Countries of recruitment

United Kingdom
England
Netherlands

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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes