Healthy SubjectsPhase 1NCT01476800
A Study to Assess Pharmacokinetic Interaction of Multiple Dose Ketoconazole on Single Dose YM178 Oral Controlled Absorption System (OCAS) in Healthy Adult Volunteers
A Phase 1 study testing YM178 OCAS and Ketoconazole in people with Healthy Subjects and Pharmacokinetics of YM178, run by Astellas Pharma Inc at 1 site in United States.
Trial summary
The purpose of this study is to assess the pharmacokinetic interaction of multiple-dose ketoconazole on single-dose YM178 OCAS and the safety and tolerability of YM178 OCAS alone and in combination with ketoconazole in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Pharmacokinetics of YM178
- What is being tested?
- YM178 OCAS and Ketoconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject, if female, must be surgically sterile (must be documented), post-menopausal (defined as at least two years without menses), or must be using double-barrier contraception or a non-hormonal IUD
- The subject, if female, must be non-lactating, and have a negative serum pregnancy test result during the study
- The subject must be in good health
- The subject must weigh at least 45 kg, and have a Body Mass Index (BMI) between 18 and 30 kg/m^2, inclusive
- The subject must have normal clinical laboratory test results or, if abnormal, are not clinically significant
- The subject must have a normal 12-lead electrocardiogram (ECG) (including normal interval durations). If abnormal, the interval durations must be deemed not clinically significant and must not exceed the following values: PR intervals must not exceed 220 milliseconds and QTc values must not exceed 450 milliseconds in Males or 470 milliseconds in females
- The subject must have negative drug and alcohol toxicology screens during the study. Any subject who tests positive for drugs or alcohol during the study will be terminated
Who cannot join
- The subject has a history of clinically significant illness (e.g., cardiovascular, hepatic, renal, or gastrointestinal abnormality within past 3 months that would preclude participation in the study
- The subject is known to have hepatitis or is positive for hepatitis A antibody IgM, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or has a positive result to tests for HIV-1 and/or HIV-2 antibodies
- The subject is known to have hypersensitivity to YM178, or ketoconazole or other imidazole compounds
- The subject has a resting supine pulse <50 bpm or >90 bpm
- The subject has orthostasis (change in pulse rate with orthostatic maneuver of >20 bpm or to a level ≥ 120 bpm)
- The subject is taking any oral hormonal contraceptive
Show all 17Show fewer
- The subject is taking a potential inhibitor of CYP3A4 or CYP2D6
- The subject has received or is anticipated to receive a prescription systemic or topical medication within past 14 days or any long-active treatments (e.g., depot formulation) within past 30 days
- The subject has received any other-the-counter medication including herbal medicines within past 14 days (occasional use of acetaminophen of up to 2000 mg/day but not more than 4 days per week is permitted)
- The subject is currently participating in another clinical trial and/or is taking or has been taking an investigational drug in the past 30 days (or 10 half-lives of the drug, whichever is longer)
- The subject anticipates an inability to abstain from alcohol, or caffeine use, or from grapefruit and grapefruit juice from 48 hours prior to the administration of the first dose of YM178 on Day 1 of Period 1 and throughout the duration of the study
- The subject has used tobacco-containing products and nicotine or nicotine-containing products in past six months
- The subject consumes more than 5 units of alcoholic beverages (one unit is 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits) per week or has a history of substance abuse, drug addiction, or alcoholism within past 2 years.
- The subject has had any blood donation or significant loss of blood or has received transfusion of any blood or blood products within 56 days of study initiation or has donated plasma within 7 days of study initiation.
- The subject has a history of psychiatric illness within past 10 years or is incapable of being compliant with the study procedures
- The subject is unable to understand verbal and/or written English or any other language in which a certified translation of the informed consent is available
- The subject has a history of benign prostatic hypertrophy or urinary incontinence
Trial locations and contacts
1 site in 1 country.
United States1 site
MDS Pharma Services (US) Inc.
Lincoln, Nebraska, 68502
About this study
Official title: A Phase 1, Open-Label, Two-Period, One-Sequence Crossover Study to Assess Pharmacokinetic Interaction of Multiple Dose Ketoconazole on Single Dose YM178 Oral Controlled Absorption System (OCAS) in Healthy Male and Female Adult Volunteers
The purpose of this study is to assess the pharmacokinetic interaction of multiple-dose ketoconazole on single-dose YM178 OCAS and the safety and tolerability of YM178 OCAS alone and in combination with ketoconazole in healthy adult volunteers.
Read the detailed description
A single oral dose of YM178 OCAS will be administered on 2 separate occasions: alone on Day 1 of Period 1 and during multiple- dosing of ketoconazole on Day 4 of Period 2. In Period 2, an oral dose of ketoconazole will be administered once daily on Days 1-9.
- Conditions
- Healthy Subjects, Pharmacokinetics of YM178
- Being tested
- YM178 OCAS, Ketoconazole
- Keywords
- Drugs, Investigational, pharmacokinetics, Urinary Bladder, Overactive, YM178, Mirabegron
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM178 OCASDrug
Also called mirabegron
oral
KetoconazoleDrug
Also called Nizoral
oral
| Study group | Role | What they receive |
|---|---|---|
| YM178 OCAS alone | Experimental | Not described Receives: Drug: YM178 OCAS |
| Ketoconazole alone | Active comparator | Not described Receives: Drug: Ketoconazole |
| YM178 OCAS and ketoconazole | Experimental | Not described Receives: Drug: YM178 OCAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) variable for YM178: Area under the plasma concentration - time curve from time of dosing to infinity (AUCinf)
Measured: Up to Day 7 in Period 1 and up to Day 10 in Perod 2
PK Variable for YM178: Maximum concentration (Cmax)
Measured: Up to Day 7 in Period 1 and up to Day 10 in Perod 2
Secondary outcomes (1)
Safety assessed by recording of adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and physical exams
Measured: Up to Day 7 in Period 1 and up to Day 10 in Period 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJul 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 Healthy SubjectsStudies 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
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Medical Director, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476800
- Sponsor's protocol ID
- 178-CL-036
- Status last verified
- Aug 2015
- First submitted
- 18 Nov 2011
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Two-Period, One-Sequence Crossover Study to Assess Pharmacokinetic Interaction of Multiple Dose Ketoconazole on Single Dose YM178 Oral Controlled Absorption System (OCAS) in Healthy Male and Female Adult Volunteers
- ClinicalTrials.gov ID
- NCT01476800
- Acronym / sponsor ID
- 178-CL-036
- Conditions
- Healthy Subjects, Pharmacokinetics of YM178
- Keywords
- Drugs, Investigational, pharmacokinetics, Urinary Bladder, Overactive, YM178, Mirabegron
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 22 Nov 2011 (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 purpose of this study is to assess the pharmacokinetic interaction of multiple-dose ketoconazole on single-dose YM178 OCAS and the safety and tolerability of YM178 OCAS alone and in combination with ketoconazole in healthy adult volunteers.
Detailed description
A single oral dose of YM178 OCAS will be administered on 2 separate occasions: alone on Day 1 of Period 1 and during multiple- dosing of ketoconazole on Day 4 of Period 2. In Period 2, an oral dose of ketoconazole will be administered once daily on Days 1-9.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| YM178 OCAS alone | Experimental | Drug: YM178 OCAS |
| Ketoconazole alone | Active comparator | Drug: Ketoconazole |
| YM178 OCAS and ketoconazole | Experimental | Drug: YM178 OCAS |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The subject, if female, must be surgically sterile (must be documented), post-menopausal (defined as at least two years without menses), or must be using double-barrier contraception or a non-hormonal IUD
- The subject, if female, must be non-lactating, and have a negative serum pregnancy test result during the study
- The subject must be in good health
- The subject must weigh at least 45 kg, and have a Body Mass Index (BMI) between 18 and 30 kg/m^2, inclusive
- The subject must have normal clinical laboratory test results or, if abnormal, are not clinically significant
Key exclusion criteria (17 listed)
- The subject has a history of clinically significant illness (e.g., cardiovascular, hepatic, renal, or gastrointestinal abnormality within past 3 months that would preclude participation in the study
- The subject is known to have hepatitis or is positive for hepatitis A antibody IgM, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or has a positive result to tests for HIV-1 and/or HIV-2 antibodies
- The subject is known to have hypersensitivity to YM178, or ketoconazole or other imidazole compounds
- The subject has a resting supine pulse <50 bpm or >90 bpm
- The subject has orthostasis (change in pulse rate with orthostatic maneuver of >20 bpm or to a level ≥ 120 bpm)
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 |
|---|---|---|
| YM178 OCASAlso: mirabegronoral | Drug | YM178 OCAS alone, YM178 OCAS and ketoconazole |
| KetoconazoleAlso: Nizoraloral | Drug | Ketoconazole alone |
Primary outcome
Pharmacokinetic (PK) variable for YM178: Area under the plasma concentration - time curve from time of dosing to infinity (AUCinf)
Time frame: Up to Day 7 in Period 1 and up to Day 10 in Perod 2
PK Variable for YM178: Maximum concentration (Cmax)
Time frame: Up to Day 7 in Period 1 and up to Day 10 in Perod 2
1 secondary outcome
Safety assessed by recording of adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and physical exams
Time frame: Up to Day 7 in Period 1 and up to Day 10 in Period 2
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 1 Sep 2015.
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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.
Senior Medical Director study director
Astellas Pharma Global Development
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 YM178 OCAS and Ketoconazole in people with Healthy Subjects and Pharmacokinetics of YM178, run by Astellas Pharma Inc at 1 site in United States.
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 7 inclusion and 17 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 1 Sep 2015. 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 United States. 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?
Pharmacokinetic (PK) variable for YM178: Area under the plasma concentration - time curve from time of dosing to infinity (AUCinf) (time frame: Up to Day 7 in Period 1 and up to Day 10 in Perod 2). The study lists 2 primary outcomes in all. 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 1 Sep 2015.