CompletedPhase 1

HMPL-689 Drug Interaction Study With CYP3A Inhibitor/CYP2C9 Inhibitor/CYP3A Inducer/PPI

United States59 participantsStarted 2022-06-01

Plain-language summary

An open-label study to determine effect of Itraconazole, Fluconazole, Rifampin, and Rabeprazole on the PK of HMPL-689

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

. Male or female between the ages of 18 and 55 years old (inclusive) at the time of informed consent.
. Body mass index (BMI) \>18 and ≤29.9 kg/m2 at screening.
. Females must be postmenopausal (defined as absence of menses for at least 1 year without alternative medical cause) or permanently sterile by total hysterectomy, bilateral oophorectomy, or bilateral salphingectomy.
. Males, including those who have had a successful vasectomy, must use a condom during sexual intercourse with women of childbearing potential starting from their first dose of study drug through 30 days after their last dose of study drug. Alternatively, abstinence is allowed if it is the normal and preferred lifestyle of the healthy volunteer.
. Must provide written informed consent prior to any study-specific screening procedures.
. Willing and able to comply with all aspects of the protocol, as determined by the PI.

Exclusion criteria

. Known history of any gastrointestinal surgery or any condition possibly affecting drug absorption (eg, cholecystectomy, gastrectomy, achlorhydria, peptic ulcer disease, history of stomach or intestinal surgery, or resection). Appendectomy and hernia repair are allowed.
. Clinically significant illness within 8 weeks or a clinically significant infection within 4 weeks prior to the first dose.

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

AUC0-t

Timeframe: From Day 1 to Day 11 (Day 12 for Rifampin)

AUC0-inf

Timeframe: From Day 1 to Day 11 (Day 12 for Rifampin)

Cmax

Timeframe: From Day 1 to Day 11 (Day 12 for Rifampin)

Trial details

NCT IDNCT05602597

SponsorHutchmed

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-06

View on ClinicalTrials.gov More Relapsed or Refractory Lymphoma 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

. Male or female between the ages of 18 and 55 years old (inclusive) at the time of informed consent.
. Body mass index (BMI) \>18 and ≤29.9 kg/m2 at screening.
. Females must be postmenopausal (defined as absence of menses for at least 1 year without alternative medical cause) or permanently sterile by total hysterectomy, bilateral oophorectomy, or bilateral salphingectomy.
. Males, including those who have had a successful vasectomy, must use a condom during sexual intercourse with women of childbearing potential starting from their first dose of study drug through 30 days after their last dose of study drug. Alternatively, abstinence is allowed if it is the normal and preferred lifestyle of the healthy volunteer.
. Must provide written informed consent prior to any study-specific screening procedures.
. Willing and able to comply with all aspects of the protocol, as determined by the PI.

Exclusion criteria

. Known history of any gastrointestinal surgery or any condition possibly affecting drug absorption (eg, cholecystectomy, gastrectomy, achlorhydria, peptic ulcer disease, history of stomach or intestinal surgery, or resection). Appendectomy and hernia repair are allowed.
. Clinically significant illness within 8 weeks or a clinically significant infection within 4 weeks prior to the first dose.