Food Effects on PharmacokineticsEarly Phase 1NCT03647202
Food Effects on Milademetan Pharmacokinetics in Healthy Participants
A Early Phase 1 study testing Milademetan Treatment A, Milademetan Treatment B and Milademetan Treatment C in people with Food Effects on Pharmacokinetics, run by Daiichi Sankyo at 1 site in United States.
Trial summary
The primary objectives of this trial are: To evaluate the effect of a high-calorie, high-fat meal on the single-dose pharmacokinetics (PK) of milademetan To evaluate the effect of a standard meal on the single-dose PK of milademetan The key secondary objective is to evaluate the safety and tolerability of single-dose… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Effects on Pharmacokinetics
- What is being tested?
- Milademetan Treatment A, Milademetan Treatment B and Milademetan Treatment C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2018to 13 Sep 2018
- Phase
- Early 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has negative urine test for drugs of abuse, alcohol and tobacco
- If female, is surgically sterile or postmenopausal
- If male, agrees to protocol-defined contraceptive methods
- Has adequate hematologic, hepatic, and renal function as defined by the protocol
- Is able and willing to follow all study procedures
- Has provided a signed informed consent
Who cannot join
- Is female who is pregnant or breastfeeding
- Is unable to swallow oral medication
- Is unable to follow study procedures
- Has creatinine clearance < 90 mL/min at screening
- Is taking or has taken any medications or therapies outside of protocol-defined parameters
- Has history of or a known allergic reaction to azole antifungal agents
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- Has any disease or condition that, per protocol or in the opinion of the investigator, might affect:
- safety and well-being of the participant or offspring
- safety of study staff
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit, Inc.
Dallas, Texas, 75247
About this study
Official title: An Open-label, Randomized, 3-period, 3-treatment Crossover Study to Evaluate the Effect of High-fat, High-calorie Food and Standard Food on the Single-dose Pharmacokinetics of Milademetan in Healthy Subjects
The primary objectives of this trial are:
- To evaluate the effect of a high-calorie, high-fat meal on the single-dose pharmacokinetics (PK) of milademetan
- To evaluate the effect of a standard meal on the single-dose PK of milademetan
Read more
The key secondary objective is to evaluate the safety and tolerability of single-dose milademetan in all treatments.
The duration of the study for each individual participant will be approximately 8 weeks from the start of Screening (within 28 days prior to dosing of study drug on Day 1) through the final Follow-up visit or phone call. Participants will remain in the Clinical Research Unit (CRU) from Study Day -2 through Study Day 20 (a total of 22 days and 21 nights).
Participants will receive 3 single doses of study drug (at least 1 week apart) over the course of 15 days.
At the investigator's discretion, participants may be asked to return to the CRU 14 days (±2 days) after final dose of study drug for a follow-up visit.
The end of the study is defined as the date of final follow-up visit of the last subject undergoing the study.
- Conditions
- Food Effects on Pharmacokinetics
- Being tested
- Milademetan Treatment A, Milademetan Treatment B, Milademetan Treatment C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milademetan Treatment ADrug
Also called Experimental product
Treatment A: Single oral dose of milademetan 160 mg capsules under fasted conditions
Milademetan Treatment BDrug
Also called Experimental product
Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal
Milademetan Treatment CDrug
Treatment C: Single oral dose of milademetan 160 mg capsules with a standard meal.
| Study group | Role | What they receive |
|---|---|---|
| Sequence ABC | Experimental | Participants receive milademetan in a fasted condition (A), then with a high-calorie, high-fat breakfast (B), then with a standard breakfast (C) - with a washout period between treatments. Receives: Drug: Milademetan Treatment A; Drug: Milademetan Treatment B; Drug: Milademetan Treatment C |
| Sequence ACB | Experimental | Participants receive milademetan in a fasted condition (A), then with a standard breakfast (C), then with a high-calorie, high-fat breakfast (B) - with a washout period between treatments. Receives: Drug: Milademetan Treatment A; Drug: Milademetan Treatment B; Drug: Milademetan Treatment C |
| Sequence BAC | Experimental | Participants receive milademetan with a high-calorie, high-fat breakfast (B), then in a fasted condition (A), then with a standard breakfast (C) - with a washout period between treatments. Receives: Drug: Milademetan Treatment A; Drug: Milademetan Treatment B; Drug: Milademetan Treatment C |
| Sequence BCA | Experimental | Participants receive milademetan with a high-calorie, high-fat breakfast (B), then with a standard breakfast (C), then in a fasted condition (A) - with a washout period between treatments. Receives: Drug: Milademetan Treatment A; Drug: Milademetan Treatment B; Drug: Milademetan Treatment C |
| Sequence CAB | Experimental | Participants receive milademetan with a standard breakfast (C), then in a fasted condition (A), then with a high-calorie, high-fat breakfast (B) - with a washout period between treatments. Receives: Drug: Milademetan Treatment A; Drug: Milademetan Treatment B; Drug: Milademetan Treatment C |
| Sequence CBA | Experimental | Participants receive milademetan with a standard breakfast (C), then with a high-calorie, high-fat breakfast (B), then in a fasted condition (A) - with a washout period between treatments. Receives: Drug: Milademetan Treatment A; Drug: Milademetan Treatment B; Drug: Milademetan Treatment C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of milademetan
Measured: predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose in each treatment period
Area under the plasma concentration-time curve (AUC) extrapolated to infinity (AUCinf) for milademetan
Measured: within 120 hours postdose in each treatment period
Secondary outcomes (6)
Time to teach maximum plasma concentration (Tmax) of milademetan
Measured: within 120 hours postdose in each treatment period
AUC from time 0 to the time of last measurable concentration (AUClast) for milademetan
Measured: within 120 hours postdose in each treatment period
Lag time (tlag) for milademetan
Tlag is used to characterize the delay in absorption of orally administered drugs
Measured: within 120 hours postdose in each treatment period
Terminal elimination half-life (t½) of milademetan
Measured: within 120 hours postdose in each treatment period
Apparent total body clearance (CL/F) of milademetan clearance (CL/F),
Measured: within 120 hours postdose in each treatment period
Apparent volume of distribution (Vz/F) of milademetan
Measured: within 120 hours postdose in each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start16 Aug 2018
- Primary completion13 Sep 2018
- Study completion13 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Effects on 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be assigned to 1 of 6 treatment sequences (Sequences ABC, ACB, BAC, BCA, CAB, or CBA), according to a pre-generated randomization scheme.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647202
- Sponsor's protocol ID
- DS3032-A-U115
- Status last verified
- Sep 2018
- First submitted
- 23 Aug 2018
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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, Randomized, 3-period, 3-treatment Crossover Study to Evaluate the Effect of High-fat, High-calorie Food and Standard Food on the Single-dose Pharmacokinetics of Milademetan in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03647202
- Acronym / sponsor ID
- DS3032-A-U115
- Conditions
- Food Effects on Pharmacokinetics
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 13 Sep 2018 (actual)
- Study completion
- 13 Sep 2018 (actual)
- First posted
- 27 Aug 2018 (actual)
- 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 primary objectives of this trial are:
- To evaluate the effect of a high-calorie, high-fat meal on the single-dose pharmacokinetics (PK) of milademetan
- To evaluate the effect of a standard meal on the single-dose PK of milademetan
The key secondary objective is to evaluate the safety and tolerability of single-dose milademetan in all treatments.
The duration of the study for each individual participant will be approximately 8 weeks from the start of Screening (within 28 days prior to dosing of study drug on Day 1) through the final Follow-up visit or phone call. Participants will remain in the Clinical Research Unit (CRU) from Study Day -2 through Study Day 20 (a total of 22 days and 21 nights).
Participants will receive 3 single doses of study drug (at least 1 week apart) over the course of 15 days.
At the investigator's discretion, participants may be asked to return to the CRU 14 days (±2 days) after final dose of study drug for a follow-up visit.
The end of the study is defined as the date of final follow-up visit of the last subject undergoing the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Participants will be assigned to 1 of 6 treatment sequences (Sequences ABC, ACB, BAC, BCA, CAB, or CBA), according to a pre-generated randomization scheme.
| Arm | Type | Receives |
|---|---|---|
| Sequence ABC | Experimental | Drug: Milademetan Treatment A, Drug: Milademetan Treatment B, Drug: Milademetan Treatment CParticipants receive milademetan in a fasted condition (A), then with a high-calorie, high-fat breakfast (B), then with a standard breakfast (C) - with a washout period between treatments. |
| Sequence ACB | Experimental | Drug: Milademetan Treatment A, Drug: Milademetan Treatment B, Drug: Milademetan Treatment CParticipants receive milademetan in a fasted condition (A), then with a standard breakfast (C), then with a high-calorie, high-fat breakfast (B) - with a washout period between treatments. |
| Sequence BAC | Experimental | Drug: Milademetan Treatment A, Drug: Milademetan Treatment B, Drug: Milademetan Treatment CParticipants receive milademetan with a high-calorie, high-fat breakfast (B), then in a fasted condition (A), then with a standard breakfast (C) - with a washout period between treatments. |
| Sequence BCA | Experimental | Drug: Milademetan Treatment A, Drug: Milademetan Treatment B, Drug: Milademetan Treatment CParticipants receive milademetan with a high-calorie, high-fat breakfast (B), then with a standard breakfast (C), then in a fasted condition (A) - with a washout period between treatments. |
| Sequence CAB | Experimental | Drug: Milademetan Treatment A, Drug: Milademetan Treatment B, Drug: Milademetan Treatment CParticipants receive milademetan with a standard breakfast (C), then in a fasted condition (A), then with a high-calorie, high-fat breakfast (B) - with a washout period between treatments. |
| Sequence CBA | Experimental | Drug: Milademetan Treatment A, Drug: Milademetan Treatment B, Drug: Milademetan Treatment CParticipants receive milademetan with a standard breakfast (C), then with a high-calorie, high-fat breakfast (B), then in a fasted condition (A) - with a washout period between treatments. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Has negative urine test for drugs of abuse, alcohol and tobacco
- If female, is surgically sterile or postmenopausal
- If male, agrees to protocol-defined contraceptive methods
- Has adequate hematologic, hepatic, and renal function as defined by the protocol
- Is able and willing to follow all study procedures
Key exclusion criteria (9 listed)
- Is female who is pregnant or breastfeeding
- Is unable to swallow oral medication
- Is unable to follow study procedures
- Has creatinine clearance < 90 mL/min at screening
- Is taking or has taken any medications or therapies outside of protocol-defined parameters
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 |
|---|---|---|
| Milademetan Treatment AAlso: Experimental productTreatment A: Single oral dose of milademetan 160 mg capsules under fasted conditions | Drug | Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA |
| Milademetan Treatment BAlso: Experimental productTreatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal | Drug | Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA |
| Milademetan Treatment CTreatment C: Single oral dose of milademetan 160 mg capsules with a standard meal. | Drug | Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA |
Primary outcome
Maximum plasma concentration (Cmax) of milademetan
Time frame: predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose in each treatment period
Area under the plasma concentration-time curve (AUC) extrapolated to infinity (AUCinf) for milademetan
Time frame: within 120 hours postdose in each treatment period
6 secondary outcomes
Time to teach maximum plasma concentration (Tmax) of milademetan
Time frame: within 120 hours postdose in each treatment period
AUC from time 0 to the time of last measurable concentration (AUClast) for milademetan
Time frame: within 120 hours postdose in each treatment period
Lag time (tlag) for milademetan
Time frame: within 120 hours postdose in each treatment period
Terminal elimination half-life (t½) of milademetan
Time frame: within 120 hours postdose in each treatment period
Apparent total body clearance (CL/F) of milademetan clearance (CL/F),
Time frame: within 120 hours postdose in each treatment period
Apparent volume of distribution (Vz/F) of milademetan
Time frame: within 120 hours postdose in each treatment period
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.
Clinical Study Leader study director
Daiichi Sankyo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Milademetan Treatment A, Milademetan Treatment B and Milademetan Treatment C in people with Food Effects on 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 6 inclusion and 9 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 plasma concentration (Cmax) of milademetan (time frame: predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose in each treatment period). 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 12 Feb 2019.