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NCT Number: NCT06492525

A Study To Evaluate The Effect Of Rifampicin Or Ltraconazole On Pharmacokinetics Of Ensartinib In Healthy Volunteers

The purpose of this study is to estimate the effect of rifampicin or itraconazole on the single dose PK of ensartinib.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Second Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male body weight ≥ 50kg, female body weight ≥ 45kg, body mass index (BMI) within the range of 19 ~ 26kg /m2;
  • Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator;
  • The subjects should took effective contraceptive measures voluntarily from informed consent until 3 months after Study Completion；
  • Able to comprehend and willing to sign an informed consent form.

Exclusion criteria

  • Those with a history of chronic systemic or serious diseases such as cardiovascular, liver, kidney, lung, gastrointestinal, nervous, musculoskeletal, hematopoietic or metabolic diseases, especially surgical conditions or conditions that may affect drug absorption, distribution, metabolism and excretion；
  • Family history or presence of long QTc syndrome; History or presence of an abnormal ECG；
  • Hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), treponema pallidum antibody or human immunodeficiency virus antigen/antibody (HIV-Ag/Ab) is positive；
  • Use of any medications (prescription drugs, over-the-counter drugs, Chinese herbal medicines, health products, moderate or strong CYP3A inhibitors or inducers, etc) within 14 days prior to the first administration；
  • Those who have special dietary requirements (habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeinated beverages) and are unable to withdraw during the trial；
  • Drug abusers, smokers or alcoholics；
  • Those with a history of fear of needles and hemophobia, difficulty in blood collection or inability to tolerate venipuncture blood collection;
  • Donation of blood ≥ 400 mL or receipt of blood products within 3 months before enrollment;
  • Receive any vaccine within 1 months before enrollment；
  • Participation in any other investigational drug study within 3 months before enrollment；
  • History of significant hypersensitivity to any drug compound or food；
  • Other conditions that, in the opinion of the investigator, are not suitable for the subject to participate in this study.

Treatment and study plan

Ensartinib

Drug

225 mg oral dose on day 1 in period 1 and on day 18 in period 2

rifampicin

Drug

600 mg QD from day 9 to day 22 in period 2

Itraconazole

Drug

200 mg QD from day 9 to day 19 in period 2

Primary outcomes

  1. Plasma AUC0-t for Ensartinib Given Alone and With Rifampicin

    Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 after Ensartinib 225 mg administration in Period 1, and at the same time points on Day 18 after Ensartinib 225 mg with rifampin administration in Period 2.

    AUC0-t is the plasma area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast).

  2. Plasma AUC0-t for Ensartinib Given Alone and With Itraconazole

    Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 hours post-dose on Day 1 after Ensartinib 100 mg administration in Period 1, and at the same time points on Day 12 after Ensartinib 100 mg with Itraconazole administration in Period 2.

    AUC0-t is the plasma area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast).

  3. Plasma AUC0-∞ for Ensartinib Given Alone and With Rifampicin

    Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 after Ensartinib 225 mg administration in Period 1, and at the same time points on Day 18 after Ensartinib 225 mg with rifampin administration in Period 2.

    AUC0-∞ is the plasma area under the plasma concentration-time profile from time 0 extrapolated to infinite time.

  4. Plasma AUC0-∞ for Ensartinib Given Alone and With Itraconazole

    Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 hours post-dose on Day 1 after Ensartinib 100 mg administration in Period 1, and at the same time points on Day 12 after Ensartinib 100 mg with Itraconazole administration in Period 2.

    AUC0-∞ is the plasma area under the plasma concentration-time profile from time 0 extrapolated to infinite time.

  5. Plasma Cmax for Ensartinib Given Alone and With Rifampicin

    Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 after Ensartinib 225 mg administration in Period 1, and at the same time points on Day 18 after Ensartinib 225 mg with rifampin administration in Period 2.

    Maximum plasma concentration

  6. Plasma Cmax for Ensartinib Given Alone and With Itraconazole

    Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 hours post-dose on Day 1 after Ensartinib 100 mg administration in Period 1, and at the same time points on Day 12 after Ensartinib 100 mg with Itraconazole administration in Period 2.

    Maximum plasma concentration

Study contacts

Contact information is provided by the study sponsor or research team.

Bo Jiang, Ph.D

CONTACT

[email protected]

0571-87783759

Sponsors and collaborators

Lead sponsor

Betta Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

A Phase 1, Open-label, 2-period, Fixed Sequence, Cross-over Study To Investigate The Effect Of Multiple Doses Of Rifampicin Or Itraconazole On The Pharmacokinetics Of Single Dose Ensartinib In Healthy Volunteers.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 9, 2024
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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