SMP-028/Oral Contraceptive Drug: Drug Interaction study
| ISRCTN | ISRCTN93391015 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93391015 |
| Secondary identifying numbers | D4050158 |
- 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
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 double-blind placebo-controlled two-sequence two-period crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled 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 | 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 hypothesis | 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]) |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | SMP-028, Microgynon 30® |
| Primary outcome measure | 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 |
| Secondary outcome measures | 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. |
| Overall study start date | 14/01/2010 |
| Overall study end date | 30/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 22 healthy female subjects (11 in each group). In order to obtain 22 completers, it is estimated that 30 subjects will be enrolled. |
| Participant 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 |
| Participant exclusion criteria | 1. Contraindications to the administration of a combined oral contraceptive (OC) pill 2. Other standard exclusion criteria |
| Recruitment start date | 14/01/2010 |
| Recruitment end date | 30/06/2010 |
Locations
Countries of recruitment
- England
- Netherlands
- 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 |
