PharmacokineticsPhase 1NCT01655056
A Study to Evaluate the Safety and Tolerability of YM150 in Healthy Caucasian and Japanese Male and Female Subjects, and to Assess the Effect That Gender May Have on Its Actions in the Body
A Phase 1 study testing YM150 in people with Pharmacokinetics and Pharmacodynamics, run by Astellas Pharma Europe B.V. at 1 site in Germany.
Trial summary
The study aims to investigate the effect of YM150 and to compare gender and ethnic differences in healthy Caucasian and Japanese male and female subjects. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Pharmacodynamics, Healthy Subjects
- What is being tested?
- YM150
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2006to Nov 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese subjects had to be born in Japan, have Japanese parents, have Japanese passports, have been resident in the West for no longer than 10 years or not at all and have a Japanese lifestyle (food habit)
- Caucasian subjects:
- Body weight:
- Males: 60-100 kg
- Females: 50-90 kg
- BMI: 18.0-27.0 kg/m2 (males and females)
Show all 11Show fewer
- Japanese subjects:
- Body weight:
- Males: 50-80 kg
- Females: 40-70 kg
- BMI: 18.0-27.0 kg/m2 (males and females)
Who cannot join
- Female subject of child-bearing potential, not practicing adequate methods to prevent pregnancies, like abstinence or double barrier methods (e.g. condom in combination with a spermicidal crème)
- Female subject showing a positive pregnancy test
- Lactating mother or woman with an intention of pregnancy
- Known or suspected hypersensitivity to YM150 or any of the constituents of the formulations used
- History of and/or any sign or symptom indicating current abnormal hemostasis or blood dyscrasia, including but not limited to neutropenia, thrombocytopenia, thrombocytopathy, thromboasthenia, hemophilia, Von Willebrand's disease, and vascular purpura, bleeding gums, or frequent nose bleeding
- Family history of congenital vascular malformation (e.g. Marfan's Syndrome) and/or bleeding disorder (e.g. hemophilia, Von Willebrand's disease, Christmas disease)
Show all 24Show fewer
- History of peptic ulcer or of any other organic lesion susceptible to bleed
- PT or aPTT at the screening visit outside the normal range
- Any surgical intervention (including tooth extraction) or trauma within the last 3 months preceding the initiation of the study
- Any clinically significant history of asthma, eczema, any other clinically significant allergic condition or previous severe hypersensitivity to any other drug
- Any clinically significant upper gastro-intestinal symptoms likely to interfere with the absorption of the drug
- History or presence of any cardiovascular disease or disorder
- History of a clinically significant ECG abnormality
- Any clinically relevant history of other disease or disorder - gastrointestinal, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic
- Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG, and clinical laboratory tests
- Abnormal heart rate and blood pressure measurements at the screening visit as follows: heart rate <40 or >90 bpm; mean systolic blood pressure <95 or >160 mmHg; mean diastolic blood pressure <40 or >95 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min)
- Regular use of any prescribed or OTC drugs in the 4 weeks prior to admission to the clinical unit OR any use of such drugs in the 2 weeks prior to admission to the clinical unit
- History of drug abuse at any time, OR any use of drugs of abuse within 3 months prior to admission to the clinical unit
- Participation in any clinical study within 3 months, or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study
- History of drinking more than 21 units of alcohol per week (1 unit = 270 ml of beer or 40 ml of spirits or 125 ml of wine) within 3 months prior to admission to the clinical unit
- History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the clinical unit
- Subject, who is anti-HAV (IgM), anti-HCV, HBsAg or HIV-1 or -2 positive
- Donation of blood (>400 ml) or blood products within 3 months prior to admission to the clinical unit or plasmapheresis within 4 weeks prior to admission to the clinical unit
- Employees of the Astellas Group or CRO involved in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of YM150 in Healthy Caucasian and Japanese Male and Female Subjects
The study aims to investigate the effect of YM150 and to compare gender and ethnic differences in healthy Caucasian and Japanese male and female subjects.
Read the detailed description
Each dose group consists of a cohort of 8 Caucasian and 8 Japanese male subjects to be randomized such that 6 subjects of each race receive active treatment and 2 subjects of each race receive matching placebo. The highest tolerated dose is repeated with a cohort of 8 Caucasian and 8 Japanese female subjects, unless emerging safety and PK information justifies higher dose levels or require additional female dose groups.
Each subject is administered a single dose YM150 or placebo on Day 1 followed by multiple doses of YM150 or placebo once daily on Days 3 to 9.
- Conditions
- Pharmacokinetics, Pharmacodynamics, Healthy Subjects, Caucasian, Japanese
- Being tested
- YM150, Placebo
- Keywords
- Pharmacokinetics, Pharmacodynamics, Phase 1, YM150, Dose-escalating, Ethnicity, Caucasian, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM150Drug
Also called darexaban
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| low male dose | Experimental | Japanese and Caucasian males Receives: Drug: YM150; Drug: Placebo |
| medium male dose | Experimental | Japanese and Caucasian males Receives: Drug: YM150; Drug: Placebo |
| high male dose | Experimental | Japanese and Caucasian males Receives: Drug: YM150; Drug: Placebo |
| high female dose | Experimental | Japanese and Caucasian females Receives: Drug: YM150; Drug: Placebo |
| highest male dose | Experimental | Japanese and Caucasian males Receives: Drug: YM150; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events
Measured: Day -21 - Day 25
Secondary outcomes (2)
Pharmacokinetics (PK) and pharmacodynamics (PD) of YM150 assessed by plasma and urine concentrations
Cmax (Maximum concentration), tmax (Time to attain Cmax), t1/2 (Apparent terminal elimination half-life), Vz/F (Apparent volume of distribution), CL/F (Apparent total body plasma clearance), CLR (Renal clearance), PTmax (Maximum Prothrombin time), aPTTmax (Maximum activated partial thromboplastin time), AUClast (AUC until last sample taken), AUC0-inf (AUC extrapolated until infinity), AUC0-24h (AUC between time 0 and 24h), Aelast (Amount excreted in urine until last sample), Ae0-inf (Amount excreted in urine extrapolated until infinity), %Excrlast, %Excr0-inf, %Excr0-24h and Ae0-24h (Amount excreted in urine between time 0 and 24h)
Measured: Day 1 - Day 11
Gender effects on the PK and PD of YM150.
Cmax, tmax, t1/2, Vz/F, CL/F, CLR, PTmax, aPTTmax, AUClast, AUC0-inf, AUC0-24h, Aelast, Ae0-inf, %Excrlast, %Excr0-inf, %Excr0-24h and Ae0-24h
Measured: Day 1 - Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startJun 2006
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Manager, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655056
- Sponsor's protocol ID
- 150-CL-006
- Other IDs
- 2004-004935-72, 2004
- Status last verified
- Jul 2012
- First submitted
- 30 Jul 2012
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of YM150 in Healthy Caucasian and Japanese Male and Female Subjects
- ClinicalTrials.gov ID
- NCT01655056
- Acronym / sponsor ID
- 150-CL-006
- Conditions
- Pharmacokinetics, Pharmacodynamics, Healthy Subjects, Caucasian, Japanese
- Keywords
- Pharmacokinetics, Pharmacodynamics, Phase 1, YM150, Dose-escalating, Ethnicity, Caucasian, Japanese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 1 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to investigate the effect of YM150 and to compare gender and ethnic differences in healthy Caucasian and Japanese male and female subjects.
Detailed description
Each dose group consists of a cohort of 8 Caucasian and 8 Japanese male subjects to be randomized such that 6 subjects of each race receive active treatment and 2 subjects of each race receive matching placebo. The highest tolerated dose is repeated with a cohort of 8 Caucasian and 8 Japanese female subjects, unless emerging safety and PK information justifies higher dose levels or require additional female dose groups.
Each subject is administered a single dose YM150 or placebo on Day 1 followed by multiple doses of YM150 or placebo once daily on Days 3 to 9.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| low male dose | Experimental | Drug: YM150, Drug: PlaceboJapanese and Caucasian males |
| medium male dose | Experimental | Drug: YM150, Drug: PlaceboJapanese and Caucasian males |
| high male dose | Experimental | Drug: YM150, Drug: PlaceboJapanese and Caucasian males |
| high female dose | Experimental | Drug: YM150, Drug: PlaceboJapanese and Caucasian females |
| highest male dose | Experimental | Drug: YM150, Drug: PlaceboJapanese and Caucasian males |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Japanese subjects had to be born in Japan, have Japanese parents, have Japanese passports, have been resident in the West for no longer than 10 years or not at all and have a Japanese lifestyle (food habit)
- Body weight:
- BMI: 18.0-27.0 kg/m2 (males and females)
- Body weight:
- BMI: 18.0-27.0 kg/m2 (males and females)
Key exclusion criteria (24 listed)
- Female subject of child-bearing potential, not practicing adequate methods to prevent pregnancies, like abstinence or double barrier methods (e.g. condom in combination with a spermicidal crème)
- Female subject showing a positive pregnancy test
- Lactating mother or woman with an intention of pregnancy
- Known or suspected hypersensitivity to YM150 or any of the constituents of the formulations used
- History of and/or any sign or symptom indicating current abnormal hemostasis or blood dyscrasia, including but not limited to neutropenia, thrombocytopenia, thrombocytopathy, thromboasthenia, hemophilia, Von Willebrand's disease, and vascular purpura, bleeding gums, or frequent nose bleeding
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 |
|---|---|---|
| YM150Also: darexabanoral | Drug | high female dose, high male dose, highest male dose, low male dose, medium male dose |
| Placebooral | Drug | high female dose, high male dose, highest male dose, low male dose, medium male dose |
Primary outcome
Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events
Time frame: Day -21 - Day 25
2 secondary outcomes
Pharmacokinetics (PK) and pharmacodynamics (PD) of YM150 assessed by plasma and urine concentrations
Time frame: Day 1 - Day 11
Gender effects on the PK and PD of YM150.
Time frame: Day 1 - Day 11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2013.
Related trials for Pharmacokinetics
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
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.
Clinical Study Manager study chair
Astellas Pharma Europe B.V.
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 YM150 in people with Pharmacokinetics and Pharmacodynamics, run by Astellas Pharma Europe B.V. at 1 site in Germany.
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 11 inclusion and 24 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 26 Jun 2013. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events (time frame: Day -21 - Day 25). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2013.