SchizophreniaPhase 1NCT02174510

A Pharmacokinetic Study of Lurasidone After Single Oral Administration in Healthy Subjects

A Phase 1 study testing 20mg lurasidone, 40mg lurasidone and 80mg lurasidone in people with Schizophrenia, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the pharmacokinetic (PK) characteristics of lurasidone after single oral administration of different doses in healthy Chinese subjects. To evaluate the safety and tolerability of lurasidone after single oral administration of different doses in healthy Chinese subjects. Read more about this study

Who is it for?: Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for: Schizophrenia
What is being tested?: 20mg lurasidone, 40mg lurasidone and 80mg lurasidone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 37 participants
Where: 1 siteChina
Study dates: Mar 2014to Apr 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

After detailed explanations of study objectives, methods and procedures, anticipated efficacy, pharmacologic actions, risks and other relevant contents, subjects are aware of all relevant information related to this study and have signed the written informed consent form voluntarily.
Male subjects are 18≤ age <40 years of age when signing the informed consent.
Subjects with body weight of 50.0≤ and ≤ 80.0 kg and BMI (body mass index) of 19.0≤ and <24.0 at screening examination.
Subjects are able to comply with all requirements during this study period, receive various physical and laboratory examinations per study protocol, and report subjective symptoms.

Who cannot join

Based on the examination results during screening period, various physical and laboratory examinations performed 1 day before medication (Day-1 ) and before administration of study drug on the medication day, there are certain medical concerns on subject's health status in principal investigator's or study supervising physician's opinions (certain treatment or medical observation are deemed necessary).
Subjects with past diabetic history.
Subjects has an HbA1c level of >6.2% at screening.
Subjects with history of gastrointestinal operations.
Because of subjects' past medical history of cardiovascular diseases, liver diseases, renal diseases, endocrine disorders, digestive diseases, hematologic diseases, respiratory diseases, mental illness, neurological disorders (especially epilepsy and other convulsive disorders) and other diseases, subjects are unsuitable to participate in this study in the principal investigator's or study supervising physician's opinions.
Subjects with past history of allergy to drugs.

Show all 20Show fewer

Subjects have consumed grapefruit or food containing grapefruit ingredients between 7 days before medication (Day -7) and administration of study drug on the medication day (Day 1). Subjects have consumed food containing hypericum perforatum L. ingredients between 14 days before medication (Day-14) and administration of study drug on the medication day (Day 1).
Subjects have taken any drugs (including over-the-counter drugs) between 7 days before medication (Day_-7) and administration of study drug on medication day.
Regular drinker (criteria are mean daily consumption ≥2 bottles of 640 mL beers or Chinese liquor≥150 mL).
Subjects are used to drink large amount (criteria are daily consumption>1.8 L) of caffeine-containing beverages (e.g. coffee, black tea, green tea, coca cola or nutritional oral solution, etc).
Subjects have history of drug abuse or positive urine drug tests.
Subjects with positive immunologic test results.
Average amount of daily smoking>20 cigarettes.
Subjects have taken other study drugs within 3 months (Day_-90~Day 1) before medication.
Subjects received lurasidone orally before.
Subjects have history of blood donations of 400 mL within 3 months (Day_-90~Day 1) before medication; 200 mL within 1 month (Day_-30~Day 1) before medication; or donation of blood components within 2 weeks (Day_-14~Day 1) before medication.
Subjects have consumed alcohol-containing food between 3 days before medication 3 (Day_-3) and before administration of study drug on medication day.
Subjects can not tolerate venipuncture or have poor peripheral venous access.
Subjects are unwilling to abstain from vigorous exercise from Day_-1 until discharge.
Other subjects who are unsuitable to participate in this study in principal investigator's or study supervising physician's opinions.

Trial locations and contacts

1 site in 1 country.

China1 site

Xuhui Center Hospital
Shanghai, Shanghai Municipality, 200031

Other trials in China

About this study

To evaluate the pharmacokinetic (PK) characteristics of lurasidone after single oral administration of different doses in healthy Chinese subjects.

To evaluate the safety and tolerability of lurasidone after single oral administration of different doses in healthy Chinese subjects.

Read the detailed description

Single administration, double-blinded, placebo-controlled (3 subjects in each group will take placebo) and 3 dose groups (20 mg, 40 mg and 80 mg). There are three groups which are 20mg lurasidone or placebo, 40mg lurasidone or placebo and 80mg lurasidone or placebo.

This study comprises a screening period (between signing of the informed consent form and Day -2), baseline period (Day -1), treatment period (Days 1-3) and ending of study examination period (Days 8-11 after the last sample collection for PK evaluation).

Conditions: Schizophrenia
Being tested: 20mg lurasidone, 40mg lurasidone, 80mg lurasidone, placebo
Keywords: pharmacokinetic, lurasidone, single dose
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

20mg lurasidoneDrug
single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.
40mg lurasidoneDrug
single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.
80mg lurasidoneDrug
single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.
placeboDrug

Study groups in NCT02174510
Study group	Role	What they receive
20mg lurasidone	Experimental	single oral lurasidone in 30 minutes after beginning of the over 350 kcal breakfast on day 1.The subjects will be follow up on day 8 to 11. Receives: Drug: 20mg lurasidone; Drug: placebo
40mg lurasidone	Experimental	single oral lurasidone in 30 minutes after beginning of the over 350 kcal breakfast on day 1.The subjects will be follow up on day 8 to 11. Receives: Drug: 40mg lurasidone; Drug: placebo
80mg lurasidone	Experimental	single oral lurasidone in 30 minutes after beginning of the over 350 kcal breakfast on day 1.The subjects will be follow up on day 8 to 11. Receives: Drug: 80mg lurasidone; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Lurasidone Cmax
Cmax：Maximum (peak) observed drug serum concentration.
Measured: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone AUC
AUC：Area under the serum concentration-time curve
Measured: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone Tmax
Tmax：Time to maximum (peak) drug serum concentration
Measured: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone λZ
λZ：Elimination rate constant
Measured: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone t1/2
t1/2 :Biological half life correlated with the elimination rate constant (kel) of semi-logarithmic concentration-time curve
Measured: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone MRT
MRT：Mean residence time.
Measured: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone CL/F
CL/F：Apparent total clearance.
Measured: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone VZ/F
VZ/F: Apparent volume of distribution at terminal phase (correlated with λz)
Measured: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Apr 2014

First posted25 Jun 2014 (estimated)
Study startMar 2014
Primary completionApr 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02174510
Sponsor's protocol ID: D1070002
Status last verified: May 2018
First submitted: 11 Feb 2014
Last updated: 11 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Hu C, Wang Y, Song R, Yu C, Luo X, Jia J. Single- and Multiple-Dose Pharmacokinetics, Safety and Tolerability of Lurasidone in Healthy Chinese Subjects. Clin Drug Investig. 2017 Sep;37(9):861-871. doi: 10.1007/s40261-017-0546-8.
PubMed 28695535

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pharmacokinetic Study of Lurasidone After Single Oral Administration in Healthy Subjects
ClinicalTrials.gov ID: NCT02174510
Acronym / sponsor ID: D1070002
Conditions: Schizophrenia
Keywords: pharmacokinetic, lurasidone, single dose
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Marubeni Pharmaceuticals (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Xuhui Central Hospital, Shanghai
Study start: Mar 2014
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 25 Jun 2014 (estimated)
Results: Posted 11 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the pharmacokinetic (PK) characteristics of lurasidone after single oral administration of different doses in healthy Chinese subjects.

To evaluate the safety and tolerability of lurasidone after single oral administration of different doses in healthy Chinese subjects.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
20mg lurasidone	Experimental	Drug: 20mg lurasidone, Drug: placebosingle oral lurasidone in 30 minutes after beginning of the over 350 kcal breakfast on day 1.The subjects will be follow up on day 8 to 11.
40mg lurasidone	Experimental	Drug: 40mg lurasidone, Drug: placebosingle oral lurasidone in 30 minutes after beginning of the over 350 kcal breakfast on day 1.The subjects will be follow up on day 8 to 11.
80mg lurasidone	Experimental	Drug: 80mg lurasidone, Drug: placebosingle oral lurasidone in 30 minutes after beginning of the over 350 kcal breakfast on day 1.The subjects will be follow up on day 8 to 11.

Who may qualify

Ages: 18 to 40 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

After detailed explanations of study objectives, methods and procedures, anticipated efficacy, pharmacologic actions, risks and other relevant contents, subjects are aware of all relevant information related to this study and have signed the written informed consent form voluntarily.
Male subjects are 18≤ age <40 years of age when signing the informed consent.
Subjects with body weight of 50.0≤ and ≤ 80.0 kg and BMI (body mass index) of 19.0≤ and <24.0 at screening examination.
Subjects are able to comply with all requirements during this study period, receive various physical and laboratory examinations per study protocol, and report subjective symptoms.

Key exclusion criteria (20 listed)

Based on the examination results during screening period, various physical and laboratory examinations performed 1 day before medication (Day-1 ) and before administration of study drug on the medication day, there are certain medical concerns on subject's health status in principal investigator's or study supervising physician's opinions (certain treatment or medical observation are deemed necessary).
Subjects with past diabetic history.
Subjects has an HbA1c level of >6.2% at screening.
Subjects with history of gastrointestinal operations.
Because of subjects' past medical history of cardiovascular diseases, liver diseases, renal diseases, endocrine disorders, digestive diseases, hematologic diseases, respiratory diseases, mental illness, neurological disorders (especially epilepsy and other convulsive disorders) and other diseases, subjects are unsuitable to participate in this study in the principal investigator's or study supervising physician's opinions.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
20mg lurasidonesingle oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.	Drug	20mg lurasidone
40mg lurasidonesingle oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.	Drug	40mg lurasidone
80mg lurasidonesingle oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.	Drug	80mg lurasidone
placebo	Drug	20mg lurasidone, 40mg lurasidone, 80mg lurasidone

Primary outcome

Lurasidone Cmax
Time frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Cmax：Maximum (peak) observed drug serum concentration.
Lurasidone AUC
Time frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
AUC：Area under the serum concentration-time curve
Lurasidone Tmax
Time frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Tmax：Time to maximum (peak) drug serum concentration
Lurasidone λZ
Time frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
λZ：Elimination rate constant
Lurasidone t1/2
Time frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
t1/2 :Biological half life correlated with the elimination rate constant (kel) of semi-logarithmic concentration-time curve
Lurasidone MRT
Time frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
MRT：Mean residence time.
Lurasidone CL/F
Time frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
CL/F：Apparent total clearance.
Lurasidone VZ/F
Time frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
VZ/F: Apparent volume of distribution at terminal phase (correlated with λz)

Results and safety

Results posted to the registry on 11 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
20mg Lurasidone	8	8
40mg Lurasidone	8	8
80mg Lurasidone	12	12
Placebo	9	9

Primary outcome: Lurasidone Cmax

Time frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/ml

Measure	20mg Lurasidone n = 8	40mg Lurasidone n = 8	80mg Lurasidone n = 12
Value	32.9 (35.4)	50.9 (29.6)	113 (39.5)

Population analysed: ALL 28 subjects who received lurasidone and have evaluable PK data.

Primary outcome: Lurasidone AUC

Time frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng･h/mL

Measure	20mg Lurasidone n = 8	40mg Lurasidone n = 8	80mg Lurasidone n = 12
AUC0-24	90.3 (26.3)	151 (26.6)	322 (34.8)
AUC0-t	97.9 (26.2)	163 (26.5)	353 (35.3)
AUC0-∞	107 (26.3)	174 (26.5)	378 (35.6)

Primary outcome: Lurasidone Tmax

Time frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose. Median (Full Range). Unit: h

Measure	20mg Lurasidone n = 8	40mg Lurasidone n = 8	80mg Lurasidone n = 12
Value	2.00 (1.0 to 2.0)	2.00 (1.5 to 3.0)	1.50 (1.0 to 2.0)

Primary outcome: Lurasidone λZ

Time frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: 1/h

Measure	20mg Lurasidone n = 8	40mg Lurasidone n = 8	80mg Lurasidone n = 12
Value	0.0271 (26)	0.0383 (32.9)	0.0383 (17.4)

Adverse events

Time frame: From just after use of the study drug to the study-ending evaluation, up to 11 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
20mg Lurasidone	0 of 8 (0%)	5 of 8 (62.5%)	Not reported
40mg Lurasidone	0 of 8 (0%)	7 of 8 (87.5%)	Not reported
80mg Lurasidone	0 of 12 (0%)	12 of 12 (100%)	Not reported
Placebo	0 of 9 (0%)	5 of 9 (55.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28695535Hu C, Wang Y, Song R, Yu C, Luo X, Jia J. Single- and Multiple-Dose Pharmacokinetics, Safety and Tolerability of Lurasidone in Healthy Chinese Subjects. Clin Drug Investig. 2017 Sep;37(9):861-871. doi: 10.1007/s40261-017-0546-8.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

ChaoYing Hu, MD principal investigator

Xuhui Center Hospital, Shanghai

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 20mg lurasidone, 40mg lurasidone and 80mg lurasidone in people with Schizophrenia, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lurasidone Cmax (time frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02174510, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.