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Healthy VolunteersPhase 1Z650NCT05057949

A Study to Evaluate Drug-Drug Interaction of Larotinib With Itraconazole and Rifampin in Healthy Adult Participants

A Phase 1 study testing Larotinib, Rifampin and Itraconazole in people with Healthy Volunteers, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to characterize the effect of rifampin (Part A) and itraconazole(Part B) on the single-dose pharmacokinetics (PK) of Larotinib in healthy adult participants. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Larotinib, Rifampin and Itraconazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
24 Nov 2021to 28 Sep 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The informed consent was signed before the study, and the content, process and possible adverse reactions of the study were fully understood;
  • Without Plan for pregnancy or pregnant within 6 months from screening to the last dose of the study drug;
  • Healthy, adult, male or female, 18 - 55 years of age;
  • Male subjects should weigh at least 50 kg and female subjects should weigh at least 45 kg. Body mass index (BMI) ≥18.0 and ≤28.0 kg/m2;
  • Subjects, who are healthy, as having no clinically significant abnormalities in vital signs and physical examination.

Who cannot join

  • Average daily smoking >5 cigarettes in 3 months before the study;
  • Known allergic reactions or hypersensitivity to any excipient of the study drug formulation(s).
  • History of alcoholism(defined as Alcohol consumption of > 14 units/week);
  • Those with positive urine drug screening or those with a history of drug abuse or drug use in the past five years ;
  • Blood donation or significant blood loss (>450 mL) within 3 months prior to screening;
  • Have dysphagia or have gastrointestinal, liver, or kidney disease (whether cured or not) that affects drug absorption or excretion within 6 months prior to screening;
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  • Have any medical condition that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or stomach and duodenal ulcers ;
  • Use of any prescription drugs, over-the-counter drugs, any vitamin products or herbal medicines in the 14 days prior to screening;
  • Any drugs that changed the activity of liver drug enzymes, such as barbiturates and rifampicin, were taken within 30 days before screening;
  • Have taken the following inhibitors or inducers of CYP3A4, CYP2C8, CYP2C19 and P-GP within 30 days before screening;
  • Patients who had taken special diet (including pitaya, mango, grapefruit, etc.) or had strenuous exercise, or had other factors affecting drug absorption, distribution, metabolism and excretion, as judged by the researcher, within 14 days before screening ;
  • Participants who have participated in any drug clinical trials within 3 months prior to screening and have used the test drug (subjects may be enrolled in the study if they dropped out of the study prior to dosing, i.e., were not randomized or received dosing) ;
  • Abnormal abdominal ultrasonography, chest radiography, ECG examination is clinically significant, or the corrected QT interval (QTcF) of ECG >470ms during screening period ;
  • Female subjects were lactating or had positive blood pregnancy results at screening or check in;
  • Laboratory examination is abnormal and clinically significant, or the following diseases (including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, tumor, lung, immune, psychiatric or cardiovascular and cerebrovascular diseases) are clinically significant as found within 12 months prior to screening;
  • Viral hepatitis (including hepatitis B and C), HIV antigen/antibody or treponema pallidum antibody was positive at screening;
  • Acute illness or concomitant medication was occurred from the screening to the first administration of the experimental drug;
  • Subjects who consume chocolate, any food or drink containing caffeine or rich in xanthine within 24 hours before taking the study drug;
  • Alcohol breath test is positive at check-in.
  • Subjects who received vaccination within 28 days prior to screening or who plan to receive vaccination during the trial ;
  • The investigator deemed the subject unsuitable for this study for any reason

Trial locations and contacts

1 site in 1 country.

China1 site

  • First Hospital of Jilin University

    Changchun, Jilin, 130000

Other trials in China

About this study

Official title: A Single-center, Open, Self-controlled Design Clinical Study to Evaluate the Pharmacokinetic Effects of Rifampicin or Itraconazole on Single-dose Laolotinib Mesylate Capsules in Healthy Subjects

The purpose of this study is to characterize the effect of rifampin (Part A) and itraconazole(Part B) on the single-dose pharmacokinetics (PK) of Larotinib in healthy adult participants.

Read the detailed description

The drug being tested in this study is called Larotinib (Z650). The study assessed the drug-drug interaction of Larotinib with either a strong cytochrome P-450 (CYP)3A inducer, rifampin (Part A) , or with a strong CYP3A inhibitor itraconazole (Part B) in healthy adult participants.

Being tested
Larotinib, Rifampin, Itraconazole

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LarotinibDrug

    Also called Z650

    Larotinib Capsules

  • RifampinDrug

    Also called Rifampin Capsules

    Rifampin Capsules

  • ItraconazoleDrug

    Also called Itraconazole Capsules

    Itraconazole Capsules

Study groups in NCT05057949
Study groupRoleWhat they receive
Part A, Treatment Sequence(Larotinib-Larotinib/Rifampin)ExperimentalLarotinib , capsules (150mg*2+50mg*1), at Hour 0 on Day 1 followed by an overnight fast. On Days 15 to 26, participants received rifampin 600 mg as capsules, orally, once daily (QD) and Larotinib 350 mg as capsules, orally was coadministered on Day 20. There was a washout period of 13 days between the two treatments.
Receives: Drug: Larotinib; Drug: Rifampin
Part B, Treatment Sequence(Larotinib-Larotinib/itraconazole)ExperimentalLarotinib , capsules (150mg*2+50mg*1), at Hour 0 on Day 1 followed by an overnight fast. On Days 15 to Day 25, participants received itraconazole 200 mg solution, orally, once daily (QD) on Days 15 to Day 25 and a single oral dose of Larotinib 350 mg as capsule was coadministered on Day 19 (Treatment B). There was a washout period of 13 days between the two treatments.
Receives: Drug: Larotinib; Drug: Itraconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax

    Maximum Observed Plasma Concentration of Larotinib

    Measured: Day 1 pre-dose at multiple time points (up to 192 hours) post-dose

  2. AUC∞

    Area Under the Plasma Concentration-time Curve from Time 0 to Infinity, calculated using the observed value of the last quantifiable concentration for Larotinib

    Measured: Day 1 pre-dose at multiple time points (up to 192 hours) post-dose

Secondary outcomes (2)

  1. AUClast

    Area Under the Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Larotinib

    Measured: Day 1 pre-dose at multiple time points (up to 192 hours) post-dose

  2. Tmax

    Time to Reach the Maximum Plasma Concentration (Cmax) for Larotinib

    Measured: Day 1 pre-dose at multiple time points (up to 192 hours) post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2021
  2. Study start24 Nov 2021
  3. Primary completion17 Feb 2022
  4. Study completion28 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05057949
Sponsor's protocol ID
Z650-DDI-104
Acronym
Z650
Status last verified
Oct 2022
First submitted
31 Aug 2021
Last updated
18 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Larotinib, Rifampin and Itraconazole in people with Healthy Volunteers, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: Day 1 pre-dose at multiple time points (up to 192 hours) post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05057949.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.

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