Bioequivalence of Azacitidine 300 Mg Film-Coated Tablets in Adult Patients with Acute Myeloid Leukaemia (AML)

Phase 1

Recruiting

• Conditions: Acute Myeloid Leukaemia
• Interventions: Drug: Azacitidine; Drug: Onureg

• Registration Number: NCT06326697
• Lead Sponsor: Hikma Pharmaceuticals LLC

Brief Summary

A Randomized, Single Oral Dose, Open Label, Two Treatment, Crossover study to investigate the bioequivalence of the Test Product Azacitidine 300 mg Film coated tablets relative to Reference Product Onureg® 300 mg Film Coated Tablets in adult patients with AML under fasting conditions

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-11
• Study First Submitted QC: 2024-03-17
• Study First Posted: 2024-03-22
• Study Start: 2024-05-02
• Last Update Submitted: 2025-03-23
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Patients age ≥ 18 years of age at the time of signing the informed consent document.

2. Patients with documented diagnosis of AML according to the 2022 updates of the World Health Organization (WHO) classification of myeloid neoplasms and acute leukaemia.

3. Patients with acute myeloid leukemia who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy. The definitions of response criteria for CR or CRi are primarily those defined by the 2022 report from the European Leukemia Net (ELN) on AML as below: CR defined as bone marrow blasts <5%; absence of circulating blasts; absence of extramedullary disease; ANC ≥ 1.0 × 10^9/L (1,000/µL); platelet count ≥ 100 × 10^9/L(100 000/µL).

   CRi defined as all CR criteria, except for residual neutropenia < 1.0 × 10^9/L (1,000/µL) or thrombocytopenia < 100 × 10^9/L (100 000/µL).

4. Patients who don't have a known or suspected hypersensitivity to Azacitidine or any other ingredient used in the manufacturing of Azacitidine.

5. Patients who are physically able for appropriate pharmacokinetics sampling according to principal investigator evaluation.

6. Patients who have a haematological profile appropriate for receiving Azacitidine 300 mg dose for 4 consecutive days as per the principal investigator assessment.

7. Patients who understand and voluntarily sign a written informed consent document prior to any study related assessments/procedures are conducted.

8. Patient is capable of consent.

9. Females of childbearing potential may participate, providing the subject meets the following conditions: Negative serum pregnancy test at screening (sensitivity of at least 25 mIU/mL), and willing to use effective contraception during and up to 6 months after study.

10. Male patients must be willing to use effective contraception during and up to 3 months after the study.

Exclusion Criteria

1. Patients with history of drug or alcohol abuse.
2. Female patients who are pregnant or nursing (lactating).
3. Patients with medical condition, laboratory abnormality, or psychiatric illness that, in the opinion of the investigator, might interfere with subject safety, compliance or evaluation of the condition of the study.
4. Patients with positive blood screen for HIV, Hepatitis B (HbsAG) or Hepatitis C (HCV) virus.
5. Patients with experience in any investigational drug in a clinical study within 6 months prior to study Day 1.
6. Patients has a difficulty fasting or consuming standard meals.
7. Patients has history of difficulties in swallowing or any gastrointestinal disease which could affect the drug absorption.
8. Patients does not agree to not be engaged in strenuous exercise at least one day prior to study drug administration until donating the last sample of the study.
9. Patients does not agree to not consuming any beverages or food containing grapefruit for at least two weeks prior to first study drug administration until donating the last sample of the study.
10. Patients does not agree to not consuming any beverages or food containing methyl-xanthines e.g., caffeine (coffee, tea, cola, energy drinks, chocolate etc.) at least 48 hours prior to first study drug administration until donating the last sample of the study.
11. Patients does not agree to not consuming any alcohol containing beverages and food at least 48 hours prior to first study drug administration until donating the last sample of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test Product: Azacitidine 300 mg Film coated tablets	Azacitidine	Single oral dose of Azacitidine 300 mg Film coated tablets
Reference Product: Onureg® 300 mg Film Coated Tablets	Onureg	Single oral dose of Onureg® 300 mg Film Coated Tablets

Primary Outcome Measures

Name	Time	Method
Cmax	5 hours	Maximum measured plasma concentration over the time span specified
AUC0-t	5 hours	The area under the plasma concentration versus time curve, from time (0) to the last measurable concentration (t), as calculated by the linear trapezoidal method.

Secondary Outcome Measures

Name	Time	Method
Adverse Events (AEs)	Day 4	Adverse Events (AEs)
Change in clinical safety labs	Day 4	Descriptive Change in clinical safety labs
AUC0-∞	5 hours	The area under the plasma concentration versus time curve from time (0) to infinity.
Kel	5 hours	Apparent first-order elimination or terminal rate constant
T1/2el	5 hours	The elimination or terminal half-life.
Tmax	5 hours	Time of the maximum measured plasma concentration.

Trial Locations

Locations (1)

King Faisal Specialist Hospital and Research Centre; 🇸🇦 Riyadh, Saudi Arabia