Condition category
Digestive System
Date applied
29/01/2009
Date assigned
20/04/2009
Last edited
30/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Shelda Alcock

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

D1050264

Study information

Scientific title

The effect of varying degrees of hepatic impairment on the single dose safety and pharmacokinetic profile of lurasidone: an open-label phase I single dose non-randomised oral administration study

Acronym

Study hypothesis

Primary: to assess the effect of varying degrees of hepatic impairment on the pharmacokinetics of lurasidone
Secondary: to assess the effect of varying degrees of hepatic impairment on the safety of lurasidone

Ethics approval

1. Czech Republic: Ethics Committee for Clinical and Experimental Medicine and Faculty Thomayer Hospital approved 6th November 2008
2. Slovak Republic: Ethics Committee FNsP Bratislava approved 28th October 2008

Study design

Open-label phase I single dose non-randomised oral administration study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Hepatic impairment

Intervention

All patients will receive a single oral 20 mg dose of lurasidone and be followed up for 9 days.

Intervention type

Drug

Phase

Phase I

Drug names

Lurasidone

Primary outcome measures

Pharmacokinetics will be assessed as follows:
1. Primary parameters: AUC0-last, Cmax, calculated once at the completion of the trial, using data from blood samples collected from dosing up to 168 hours post-dose
2. Secondary parameters: AUC0-8, CL/F, tmax, t½, Vz/ F and λz, collected once at the completion of the trial, using data from blood samples collected from dosing up to 168 hours post-dose

Secondary outcome measures

Safety will be assessed by using the following endpoints:
1. Spontaneous adverse event reporting
2. Clinical laboratory tests (clinical chemistry including prolactin, haematology including coagulation, and urinalysis)
3. Concomitant medication review
4. Vital sign assessments (supine blood pressure, heart rate, and body temperature)
5. 12-lead ECG
6. Complete physical examinations

Collected once at the completion of the trial, using data from blood samples collected from dosing up to 168 hours post-dose.

Overall trial start date

12/11/2008

Overall trial end date

31/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Main criteria:
1. Subject is male or female
2. Subject is between 18 to 75 years of age, inclusive
3. Body mass index (BMI) between 18 to 34 kg/m^2, inclusive, and a minimum body weight of 50 kg
4. Subject is informed of the nature of the study and has given written consent prior to initiating any study procedure
5. Subjects able to comply with all aspects of the protocol

Hepatic impairment subjects:
6. Subjects with Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment
7. Subject's hepatic disease is deemed stable by the Investigator
8. Subject's pre-study clinical laboratory findings are within normal range or if outside of the normal range, deemed associated with underlying hepatic dysfunction or not clinically significant in the opinion of the Investigator

Normal hepatic function subjects:
9. Subject is considered to be in good health in the opinion of the Investigator, as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and standard laboratory tests

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15 - 18 patients with hepatic impairment; 6 healthy subjects; minimum 21 in study

Participant exclusion criteria

1. Subject has had a clinically significant intercurrent illness in the four weeks before screening
2. Subject shows evidence of a clinically significant underlying medical condition, that, in the opinion of the Investigator, would represent a risk of study participation
3. History of or suspicion of significant gastrointestinal bleeding within the preceding 2 months
4. Any disorder (other than hepatic impairment, appendectomy, and cholecystectomy) that may alter the absorption, distribution, metabolism or excretion of drugs
5. History of clinically significant drug allergy including a history of atopic allergy (asthma, urticaria, or eczematous dermatitis)
6. Pregnant or lactating female subjects

Recruitment start date

12/11/2008

Recruitment end date

31/03/2009

Locations

Countries of recruitment

Czech Republic, Slovakia

Trial participating centre

Dainippon Sumitomo Pharma Europe Ltd
London
SW1E 6QT
United Kingdom

Sponsor information

Organisation

Dainippon Sumitomo Pharma Europe Ltd (UK)

Sponsor details

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