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Drug-Drug Interaction Study of Vorolanib Tablets in Healthy Participants

3 september 2026 uppdaterad av: Betta Pharmaceuticals Co., Ltd.

A Single-Center, Open-Label, Same-Subject Sequential Crossover Clinical Trial to Evaluate the Effects of Rifampicin or Itraconazole on the Pharmacokinetics of Vorolanib Tablets in Healthy Participants

This study adopts a single-center, open-label, same-subject sequential crossover clinical trial design, aiming to evaluate the effects of oral administration of rifampicin or itraconazole on the pharmacokinetic profiles of vorolanib tablets in healthy trial participants. The study consists of two treatment groups.

The rifampicin group is planned to enroll 18 healthy trial participants. Participants will receive a single oral dose of vorolanib tablets on the morning of Day 1, and continuous oral administration of rifampicin every morning from Day 6 to Day 17. On the morning of Day 15, participants will take vorolanib tablets and rifampicin.

The itraconazole group is planned to enroll 18 healthy trial participants to evaluate the effect of itraconazole on the pharmacokinetic profiles of vorolanib tablets. Participants will receive a single oral dose of vorolanib tablets on the morning of Day 1, and continuous oral administration of itraconazole every morning from Day 6 to Day 13. On the morning of Day 9, participants will take vorolanib tablets and itraconazole.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Beräknad)

36

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310052
        • Rekrytering
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Ja

Beskrivning

Inclusion Criteria:

  • 1. Body weight: ≥45 kg for females and ≥50 kg for males; body mass index (BMI) at screening ranging from 19 to 26 kg/m² (inclusive) [BMI = weight (kg)/height² (m²)];
  • 2. Results of examinations at screening and baseline (including physical examination, vital signs, laboratory tests: complete blood count, blood biochemistry, coagulation function, urinalysis, electrocardiogram, chest X-ray, etc.) are within normal limits, or abnormalities are present but judged by the investigator to have no clinical significance.

Exclusion Criteria:

  • 1. History of chronic systemic or severe diseases involving the cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, musculoskeletal, hematopoietic or metabolic systems, particularly surgical conditions or illnesses that may affect drug absorption, distribution, metabolism and excretion;
  • 2. A personal or family history of long QT syndrome, or QTcF interval >450 ms in males and >470 ms in females; clinically significant ventricular arrhythmias and conduction blocks;
  • 3. Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health supplements within 14 days prior to screening;
  • 4. Special dietary requirements (habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeine-containing beverages) and inability to abstain during the trial; inability to accept standardized meals during hospitalization;
  • 5. Weekly alcohol intake of ≥14 alcohol units within 3 months before screening or positive breath alcohol test prior to enrolment; participants who cannot refrain from alcohol consumption throughout the study from signing the informed consent form until study completion.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: The rifampicin group
Participants will receive a single oral dose of vorolanib tablets on the morning of Day 1, and continuous oral administration of rifampicin every morning from Day 6 to Day 17. On the morning of Day 15, participants will take vorolanib tablets and rifampicin.
Participants will receive a single oral dose of vorolanib tablets on the morning of Day 1, and continuous oral administration of rifampicin every morning from Day 6 to Day 17. On the morning of Day 15, participants will take vorolanib tablets and rifampicin.
Experimentell: The itraconazole group
Participants will receive a single oral dose of vorolanib tablets on the morning of Day 1, and continuous oral administration of itraconazole every morning from Day 6 to Day 13. On the morning of Day 9, participants will take vorolanib tablets and itraconazole.
Participants will receive a single oral dose of vorolanib tablets on the morning of Day 1, and continuous oral administration of itraconazole every morning from Day 6 to Day 13. On the morning of Day 9, participants will take vorolanib tablets and itraconazole.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Maximum plasma concentration (Cmax)
Tidsram: From pre-dose to 72 hours post-dose in rifampicin group. From pre-dose to 120 hours post-dose in itraconazole group.
From pre-dose to 72 hours post-dose in rifampicin group. From pre-dose to 120 hours post-dose in itraconazole group.
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC₀-t)
Tidsram: From pre-dose to 72 hours post-dose in rifampicin group. From pre-dose to 120 hours post-dose in itraconazole group.
From pre-dose to 72 hours post-dose in rifampicin group. From pre-dose to 120 hours post-dose in itraconazole group.
Area under the plasma concentration-time curve from time 0 to infinity (AUC₀-∞)
Tidsram: From pre-dose to 72 hours post-dose in rifampicin group. From pre-dose to 120 hours post-dose in itraconazole group.
From pre-dose to 72 hours post-dose in rifampicin group. From pre-dose to 120 hours post-dose in itraconazole group.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 januari 2027

Avslutad studie (Beräknad)

1 mars 2027

Studieregistreringsdatum

Först inskickad

3 september 2026

Först inskickad som uppfyllde QC-kriterierna

3 september 2026

Första postat (Faktisk)

9 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 september 2026

Senast verifierad

1 september 2026

Mer information

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