Safety of HRX215 in Patients After Minor and Major Liver Resection

Condition(s) studied

Investigational drug(s) / intervention(s)

HRX215 capsules: HRX215 250 mg orally twice daily for a total treatment duration of 28 days

Placebo capsules: placebo matching appearance of HRX215, orally twice daily for a total treatment duration of 28 days

Study summary

The goal of this clinical trial is to learn if HRX215 is safe, tolerable and active in adults who have undergone liver resection due to colorectal carcinoma metastases.

The objectives are:

1. to learn about the safety and tolerability of HRX215
2. to learn about how the body absorbs, distributes, and gets rid of HRX215.
3. to learn about clinical activity of HRX215

Researchers will compare HRX215 to a placebo (a look-alike substance that contains no drug) to investigate safety, tolerability and clinical activity in participants taking HRX215.

Eligibility

Primary outcome measure(s)

• Adverse Events (AEs) observed — 6 months
  Incidence, severity, and relatedness of AEs/SAEs. Changes in vital signs and physical examination findings. Clinical laboratory investigation.
• HRX215 plasma levels — 28 days
  Levels of drug (HRX215) at selected time intervals after drug administration

Trial sites (14)