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 range18 Years – 55 Years

SexALL

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.
✕. Evidence of a clinically significant deviation from normal in the physical examination, vital signs, or clinical laboratory determinations at screening or at Day -1 Check-in (baseline).
✕. Systolic blood of pressure \>140 mmHg or diastolic blood pressure of \> 90 mmHg.
✕. Clinically significant ECG abnormality, including a marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTcF interval of \> 450 msec), or had a family history of prolonged QTc syndrome or sudden death.
✕. History of smoking or use of nicotine containing substances within the previous 2 months, as determined by medical history or healthy volunteer's verbal report and confirmed by cotinine test at check in for each treatment period.
✕. History of drug and/or alcohol misuse prior to screening or a positive urine drug test at Screening or at Check in for each treatment period.
✕. Diagnosed with acquired immune deficiency syndrome or has performed tests that are positive for human immunodeficiency virus, hepatitis B virus (HBV), hepatitis C virus (HCV), cytomegalovirus, or pneumocystis jiroveci pneumonia.

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 range18 Years – 55 Years

SexALL

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.
✕. Evidence of a clinically significant deviation from normal in the physical examination, vital signs, or clinical laboratory determinations at screening or at Day -1 Check-in (baseline).
✕. Systolic blood of pressure \>140 mmHg or diastolic blood pressure of \> 90 mmHg.
✕. Clinically significant ECG abnormality, including a marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTcF interval of \> 450 msec), or had a family history of prolonged QTc syndrome or sudden death.
✕. History of smoking or use of nicotine containing substances within the previous 2 months, as determined by medical history or healthy volunteer's verbal report and confirmed by cotinine test at check in for each treatment period.
✕. History of drug and/or alcohol misuse prior to screening or a positive urine drug test at Screening or at Check in for each treatment period.
✕. Diagnosed with acquired immune deficiency syndrome or has performed tests that are positive for human immunodeficiency virus, hepatitis B virus (HBV), hepatitis C virus (HCV), cytomegalovirus, or pneumocystis jiroveci pneumonia.