TerminatedPhase 1

A Study of Milademetan Administration on Cardiac Repolarization in Healthy Subjects

Stopped: sponsor decision

Australia6 participantsStarted 2023-04-17

Plain-language summary

This will be a Phase 1, single-center, 2-part study in healthy subjects. Parts 1 and 2 need to be conducted in sequential order.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Is capable of understanding informed consent and is willing and able to provide written informed consent.
. Is willing to comply with all protocol procedures.
. Healthy, male, nonsmoking (for at least 90 days) subjects from 18 through 55 years of age, inclusive, at Screening, and healthy, female, nonsmoking (for at least 90 days) subjects of nonchildbearing potential from 18 through 55 years of age, inclusive, at Screening.
. Body weight \> 50 kg, body mass index between 18.0 and 30 kg/m2, inclusive.

Exclusion criteria

. Past or present clinically relevant systemic disease as judged by the Investigator including, but not limited to, clinically relevant medical abnormalities such as psychiatric, neurologic, pulmonary, respiratory, cardiac, gastrointestinal, genitourinary, renal, hepatic, metabolic, endocrinologic, hematological, or autoimmune disorders making implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study in the opinion of the Investigator.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with adverse events (AEs)

Timeframe: Part 1:Up to 15 days

Number of participants with adverse events (AEs)

Timeframe: Part 2: Up to 25 days

Incidence of laboratory abnormalities based on hematology test results

Timeframe: Part 1:Up to 15 days

Incidence of laboratory abnormalities based on hematology test results

Timeframe: Part 2: Up to 25 days

Incidence of laboratory abnormalities based on clinical chemistry test results

Timeframe: Part 1:Up to 15 days

Incidence of laboratory abnormalities based on clinical chemistry test results

Timeframe: Part 2: Up to 25 days

Incidence of laboratory abnormalities based on urinalysis test results

Timeframe: Part 1:Up to 15 days

Trial details

NCT IDNCT05758818

SponsorRain Oncology Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-08

View on ClinicalTrials.gov More Cardiac Repolarization trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Is capable of understanding informed consent and is willing and able to provide written informed consent.
. Is willing to comply with all protocol procedures.
. Healthy, male, nonsmoking (for at least 90 days) subjects from 18 through 55 years of age, inclusive, at Screening, and healthy, female, nonsmoking (for at least 90 days) subjects of nonchildbearing potential from 18 through 55 years of age, inclusive, at Screening.
. Body weight \> 50 kg, body mass index between 18.0 and 30 kg/m2, inclusive.

Exclusion criteria

. Past or present clinically relevant systemic disease as judged by the Investigator including, but not limited to, clinically relevant medical abnormalities such as psychiatric, neurologic, pulmonary, respiratory, cardiac, gastrointestinal, genitourinary, renal, hepatic, metabolic, endocrinologic, hematological, or autoimmune disorders making implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study in the opinion of the Investigator.

What they're measuring

Number of participants with adverse events (AEs)

Timeframe: Part 1:Up to 15 days

Number of participants with adverse events (AEs)

Timeframe: Part 2: Up to 25 days

Incidence of laboratory abnormalities based on hematology test results

Timeframe: Part 1:Up to 15 days

Incidence of laboratory abnormalities based on hematology test results

Timeframe: Part 2: Up to 25 days

Incidence of laboratory abnormalities based on clinical chemistry test results

Timeframe: Part 1:Up to 15 days

Incidence of laboratory abnormalities based on clinical chemistry test results

Timeframe: Part 2: Up to 25 days

Incidence of laboratory abnormalities based on urinalysis test results

Timeframe: Part 1:Up to 15 days