A Bioequivalence study of Azacitidine Tablets under Fasting Condition in Patients with Acute Myeloid Leukaemia in Remission Phase.
- Conditions
- Health Condition 1: C929- Myeloid leukemia, unspecified
- Registration Number
- CTRI/2023/06/054386
- Lead Sponsor
- Intas Pharmaceuticals Ltd., India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Participants are eligible to be included in the study only if all of the following criteria apply:
1 Must sign an ICF indicating that the participant understands the purpose of, and procedures required for the studyand in this protocol and is willing to participate in the study.
2 Man or Woman participant must be greater than or equal to 18 years of age, at the time of signing the informed consent.
3 Participant with documented history of acute myeloid leukaemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.
4 Participant meeting either of following:• Participants who will be initiating the treatment with azacitidine 300 mg tablets as per the independent clinical judgment of treating physician OR • Who are already receiving azacitidine 300 mg tablets.
5.Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
6 A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
• Is not a woman of childbearing potential (WOCBP) OR• Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency when used consistently and correctly,during the intervention period and for at least 6 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for a period of at least 6 months after the last dose of study intervention. The investigator should evaluate the effectiveness and the potential for contraceptive method failure (e.g., noncompliance, recently initiated) of the contraceptive method in relationship to the first dose of study intervention.• A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention.• If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.• Additional requirements for pregnancy testing during and after study intervention.The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
7 Male participants are eligible to participate if they agree to the following during the intervention period and for at least 3 months after the last dose of study intervention• Must agree not to plan to father a child or donate sperm for the purpose of reproduction.PLUS EITHER •Be abstinent from heterosexual or homosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.OR Must agree to use contraception/barrier as detailed below-a male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person.- male participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak when having sexual intercourse with a woman of chi
Any potential participant who meets any of the following criteria will be excluded from participating
in the study:1 Documented medical history of uncontrolled, clinically significant intercurrent cardiac,vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic,psychiatric, or metabolic disturbances or any other medical condition(s) for which, in the opinion of the investigator, participation would not be in the best interest of the participant(e.g., compromise the well-being) or that could prevent, limit, or confound the protocol specified assessments.2 Known allergies, hypersensitivity, or intolerance to any of the study interventions, or components/excipients thereof (refer to the US prescribing information and Summary of Product Characteristics of ONUREG, or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study.3 Contraindications to the use of oral azacitidine as per US prescribing information and Summary of Product Characteristics of ONUREG.4 Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of investigational intervention.
5 Positive hepatitis C antibody test result at screening or within 3 months prior to starting investigational intervention. NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be
enrolled only if a confirmatory negative hepatitis C RNA test is obtained 6 Has known human immunodeficiency virus (HIV) seropositive status, or positive HIV antibody test at screening.7 Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment) 8 Proven central nervous system leukemia 9 History of drug or alcohol abuse within 1 year prior to screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at baseline, which is not due to current medical therapy.10 History of malignancy except disease under study, within the past 1 year except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of
metastatic disease for 3 years; carcinoma in situ of the cervix; myelodysplastic disease or CMML; or malignancy, which is considered cured with minimal risk of recurrence 11 Received an investigational intervention or used an invasive investigational medical device within 30 days or 5 half-lives prior to Baseline, whichever is longer, before the signing the consent or is currently enrolled in an investigational study.12 Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the investigational intervention).13 Donated blood or blood products or had substantial loss of blood (more than 350 mL) within 3 months before the first administration of study drug or intention to donate blood or blood
products during the study
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To characterize the pharmacokinetic profile in <br/ ><br>participants with acute myeloid leukaemia in <br/ ><br>remission phase.Timepoint: Timepoint (Day 1, Day 2 and and <br/ ><br>Day 3)
- Secondary Outcome Measures
Name Time Method To characterize the additional pharmacokinetic profile in participants with acute myeloid leukaemia in remission phase.Timepoint: Timepoint (Day 1, Day 2 and and <br/ ><br>Day 3);To compare the safety in participants with <br/ ><br>acute myeloid leukaemia in remission phase.Timepoint: As per Frequency and/or incidence of significant clinical signs and symptoms.