PharmacokineticsPhase 1NCT02790671
A Study to Determine the Effects of Itraconazole on the Pharmacokinetics (PK) of DS-8500 in Healthy Subjects
A Phase 1 study testing DS-8500a and Itraconazole in people with Pharmacokinetics, run by Daiichi Sankyo at 1 site in United States.
Trial summary
Study will assess the effects of itraconazole on the pharmacokinetic (PK) parameters of single-dose DS-8500a in healthy subjects. This is an open-label study in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- DS-8500a and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Jun 2016
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects between 18 and 45 y of age, with a Body-Mass Index (BMI) of 18 kg/m2 to 30 kg/m2, inclusive, at Screening.
- Good health as determined by evaluations performed at Screening and during Enrollment on Day -1.
- Negative serum pregnancy test at Screening and a negative urine pregnancy test during Enrollment on Day -1 for all female subjects. Additionally, female subjects must be:
- Surgically sterile (ie, bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 mo prior to dosing)
- Naturally postmenopausal (spontaneous cessation of menses) for at least 24 consecutive mo prior to dosing, with a follicle stimulating hormone (FSH) level at Screening of ≥ 40 mIU/mL
- Non-lactating
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- Male subjects must agree to contraception (condom with spermicide) in addition to having their female partner (if of childbearing potential) use another form of contraception (eg, an intrauterine device, diaphragm with spermicide, oral contraceptive, injectables, or subdermal hormonal implant) from the first dose until 12 wk following last administration. Also, male subjects must not donate sperm during the study and afterwards for a period of 12 wk.
- Provided written informed consent prior to participating in the study. Able to understand and willing to comply with all the study requirements, and willing to allow the collection of all blood and urine specimens.
- Negative urine test for drugs of abuse (opiates, benzodiazepines, amphetamines, cannabinoids, cocaine, barbiturates, phencyclidine), cotinine, and alcohol at Screening and During Enrollment on Day -1.
- Willingness to abstain from grapefruit/grapefruit juice and Seville oranges 10 d before the first dose of study drug on Day 1 until the end of the study on Day 31.
- Willingness to refrain from consuming food or beverages containing caffeine/xanthine and alcohol 24 h prior to Enrollment on Day -1 until the end of the study on Day 31.
Who cannot join
- History or current evidence of clinically significant cardiac, hepatic, renal, pulmonary, endocrine/metabolic, neurologic, infectious, gastrointestinal (ie, any condition which may affect drug absorption), hematologic, or oncologic disease.
- Laboratory results (serum chemistry, hematology, and urinalysis) outside of the normal range and considered clinically significant in the opinion of the PI. Liver function (AST, ALT, bilirubin) test results must be below the ULN at Screening and during Enrollment on Day -1.
- A QTcF interval duration > 450 msec at Screening.
- Participation in a previous DS-8500a study, or dosing with itraconazole, within 6 mo prior to the first dose.
- Known sensitivity to product components of DS-8500a and/or itraconazole.
- Current participation in another investigational study or prior participation in an investigational study within the past 30 d prior to the first dose.
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- Use of any prescription or over-the-counter (OTC) medications (systemic or topical), vitamins, or dietary/herbal supplements, including St John's Wort (hypericin), within 14 d prior to the first dose.
- Consumption of more than 28 units of alcohol per wk (males) or 14 units of alcohol per wk (females), where 1 unit of alcohol equals 1/2 pint of beer, 4 ounces of wine, or 1 ounce of spirits, or significant history of alcoholism or drug/chemical abuse within the last 2 y.
- Use of tobacco products or nicotine-containing products, including smoking cessation aids, such as gums or patches, within 6 mo prior to the first dose.
- Positive test result for HBsAg, HCV, or HIV antibody.
- Employment by the clinic.
- Familial relationship (spouse and/or first degree relative) with another study participant.
- Any other reason that, in the opinion of the PI, precludes subject participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, One-Sequence, Two-Period Study to Evaluate the Effects of Itraconazole on the Pharmacokinetics of DS-8500a in Healthy Subjects
Study will assess the effects of itraconazole on the pharmacokinetic (PK) parameters of single-dose DS-8500a in healthy subjects. This is an open-label study in healthy subjects.
- Conditions
- Pharmacokinetics
- Being tested
- DS-8500a, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-8500aDrug
DS-8500a 25mg tablet
ItraconazoleDrug
200mg itraconazole
| Study group | Role | What they receive |
|---|---|---|
| single study arm | Experimental | DS-8500a and itraconazole Receives: Drug: DS-8500a; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum concentration (Cmax) of DS-8500a
To assess the effects of itraconazole on the pharmacokinetic (PK) parameters of single-dose DS-8500a
Measured: Day 1 to Day 6
time of maximum concentration (Tmax) of DS-8500a
To assess the effects of itraconazole on the pharmacokinetic (PK) parameters of single-dose DS-8500a
Measured: Day 1 to Day 6
Area under the concentration curve (AUC) of DS-8500a
To assess the effects of itraconazole on the pharmacokinetic (PK) parameters of single-dose DS-8500a
Measured: Day 1 to Day 6
Secondary outcomes (5)
Number and severity of adverse events
To assess the the safety of DS-8500a
Measured: Day 1 to Day 31
change in physical examination findings
To assess the the safety of DS-8500a
Measured: Day 1 to Day 31
change in 12-lead electrocardiogram
To assess the the safety of DS-8500a
Measured: Day 1 to Day 31
change in vital sign measurements
To assess the the safety of DS-8500a
Measured: Day 1 to Day 31
change in clinical laboratory test results
To assess the the safety of DS-8500a
Measured: Day 1 to Day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2016
- Study completionJun 2016
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.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790671
- Sponsor's protocol ID
- DS8500-A-U109
- Status last verified
- Aug 2016
- First submitted
- 31 May 2016
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, One-Sequence, Two-Period Study to Evaluate the Effects of Itraconazole on the Pharmacokinetics of DS-8500a in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02790671
- Acronym / sponsor ID
- DS8500-A-U109
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Jun 2016 (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.
Study will assess the effects of itraconazole on the pharmacokinetic (PK) parameters of single-dose DS-8500a in healthy subjects. This is an open-label study in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single study arm | Experimental | Drug: DS-8500a, Drug: ItraconazoleDS-8500a and itraconazole |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male and female subjects between 18 and 45 y of age, with a Body-Mass Index (BMI) of 18 kg/m2 to 30 kg/m2, inclusive, at Screening.
- Good health as determined by evaluations performed at Screening and during Enrollment on Day -1.
- Negative serum pregnancy test at Screening and a negative urine pregnancy test during Enrollment on Day -1 for all female subjects. Additionally, female subjects must be:
- Male subjects must agree to contraception (condom with spermicide) in addition to having their female partner (if of childbearing potential) use another form of contraception (eg, an intrauterine device, diaphragm with spermicide, oral contraceptive, injectables, or subdermal hormonal implant) from the first dose until 12 wk following last administration. Also, male subjects must not donate sperm during the study and afterwards for a period of 12 wk.
- Provided written informed consent prior to participating in the study. Able to understand and willing to comply with all the study requirements, and willing to allow the collection of all blood and urine specimens.
Key exclusion criteria (13 listed)
- History or current evidence of clinically significant cardiac, hepatic, renal, pulmonary, endocrine/metabolic, neurologic, infectious, gastrointestinal (ie, any condition which may affect drug absorption), hematologic, or oncologic disease.
- Laboratory results (serum chemistry, hematology, and urinalysis) outside of the normal range and considered clinically significant in the opinion of the PI. Liver function (AST, ALT, bilirubin) test results must be below the ULN at Screening and during Enrollment on Day -1.
- A QTcF interval duration > 450 msec at Screening.
- Participation in a previous DS-8500a study, or dosing with itraconazole, within 6 mo prior to the first dose.
- Known sensitivity to product components of DS-8500a and/or itraconazole.
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 |
|---|---|---|
| DS-8500aDS-8500a 25mg tablet | Drug | single study arm |
| Itraconazole200mg itraconazole | Drug | single study arm |
Primary outcome
maximum concentration (Cmax) of DS-8500a
Time frame: Day 1 to Day 6
To assess the effects of itraconazole on the pharmacokinetic (PK) parameters of single-dose DS-8500a
time of maximum concentration (Tmax) of DS-8500a
Time frame: Day 1 to Day 6
To assess the effects of itraconazole on the pharmacokinetic (PK) parameters of single-dose DS-8500a
Area under the concentration curve (AUC) of DS-8500a
Time frame: Day 1 to Day 6
To assess the effects of itraconazole on the pharmacokinetic (PK) parameters of single-dose DS-8500a
5 secondary outcomes
Number and severity of adverse events
Time frame: Day 1 to Day 31
change in physical examination findings
Time frame: Day 1 to Day 31
change in 12-lead electrocardiogram
Time frame: Day 1 to Day 31
change in vital sign measurements
Time frame: Day 1 to Day 31
change in clinical laboratory test results
Time frame: Day 1 to Day 31
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 12 Feb 2019.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 DS-8500a and Itraconazole in people with Pharmacokinetics, run by Daiichi Sankyo 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 11 inclusion and 13 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 12 Feb 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 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?
maximum concentration (Cmax) of DS-8500a (time frame: Day 1 to Day 6). The study lists 3 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 12 Feb 2019.