Testing ACC017 tablets in healthy adults

Study of Single Ascending Dose, Food Effects and Drug-Drug Interactions of ACC017 Tablets in Healthy Adult Participants in China: A Single-center, Randomized, Double-blind, Placebo-controlled, Two-Stage Trial

This study is testing a new tablet called ACC017 in healthy adults to see if it's safe and how it works with food and other medications.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Jiangsu Aidea Pharmaceutical Co., Ltd (Industry-sponsored)
• Drugs / interventions: osimertinib
• Locations: 1 site (Beijing)
• Trial ID: NCT06278389 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and tolerability of single ascending doses of ACC017 tablets in healthy adult participants in China. It is designed as a single-center, randomized, double-blind, placebo-controlled study that includes six dose cohorts ranging from 5 mg to 160 mg. The trial also examines the pharmacokinetic characteristics of the drug, the effects of food on its absorption, and potential drug-drug interactions when co-administered with emtricitabine and tenofovir alafenamide fumarate. Participants will receive either the ACC017 tablets or a placebo under fasting conditions, followed by a second stage that assesses the drug's performance under different dietary conditions.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 55 years who meet specific weight and BMI criteria.

Not a fit: Patients with significant medical or surgical illnesses or those outside the specified age and health criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the appropriate dosage and safety profile of ACC017 tablets for future use.

How similar studies have performed: Other studies have shown success with similar approaches in evaluating drug safety and pharmacokinetics, making this a well-explored area of research.

Eligibility criteria

Inclusion Criteria:

1. Volunteering to sign the informed consent and able to follow protocol-defined procedural requirements;
2. Aged 18 to 55 years (inclusive);
3. Male weighing ≥ 50.0 kg, female weighing ≥ 45.0 kg, and body mass index (BMI) = weight(kg)/height\^2 (m\^2) within the range of 18.5\~26 kg/m\^2 (inclusive);
4. Women of child-bearing potential (WOCBP) or men without a birth plan (including sperm or egg donation) and agreeing to use effective contraception (including one or more non-pharmacological contraceptives or non-heterosexual sexual activity in daily life) from 1 month prior to informed consent up to 3 months after the last dose of the study medication;
5. No history of significant medical or surgical illness, and normal results on vital signs, physical examination, 12-lead electrocardiogram (ECG), laboratory tests, chest X-ray and abdominal ultrasound examination during the screening period, or minor deviations from normal reference values that are not clinically significant in the judgment of the investigator.

Exclusion Criteria:

1. Occurrence or persistence of clinically significant abnormal conditions, including but not limited to cardiovascular, respiratory, gastrointestinal (any history of gastrointestinal disorders affecting the absorption of medications), urinary, hematologic and lymphatic, endocrine, musculoskeletal, immune, and neuropsychiatric disorders;
2. Possible or definite allergic reaction to the study drug, placebo, or any of the excipients contained, as judged by the investigator, or allergy (multiple drug and food sensitivities), or a history of allergic disease (e.g., asthma, urticaria, and eczematous dermatitis, etc.);
3. Acute illness, such as respiratory tract infections requiring antibiotic treatment, occurring from screening until study drug administration;
4. Inability to tolerate venipuncture, or history of needle-sickness or blood-sickness, or blood donation including component blood or significant blood loss (≥400 mL) or receipt of blood transfusion within 3 months prior to screening, or planning to donate blood during the trial period;
5. Dysphagia, or surgery within 6 months prior to screening, or surgery planned during the trial, or surgery that interferes with the absorption, distribution, metabolism, or excretion of the medication;
6. Smoking an average of \>5 cigarettes per day within 3 months prior to screening, or inability to stop using any tobacco-based product during the trial period;
7. Average weekly alcohol consumption greater than 14 units (1 unit of alcohol ≈ 360 mL of beer, or 45 mL of 40% (alcohol by volume) spirits, or 150 mL of wine) within 3 months prior to screening or inability to discontinue use of any alcohol-containing product during the trial period, or with a positive breath test for alcohol at screening;
8. Excessive consumption of tea, coffee, and/or caffeinated beverages (more than 8 cups on average per day, 1 cup ≈ 250 mL) within 3 months prior to screening, or inability to stop consuming tea, coffee, and/or caffeinated beverages during the trial period;
9. Consumption or drinking of dragon fruit, mango, grapefruit, popcorn, or foods or beverages prepared from the aforementioned fruits, or foods or beverages containing xanthines, caffeine, or alcohol (including chocolate, tea, coffee, cola, and cocoa), or any other special diet that interferes with the absorption, distribution, metabolism, or excretion of the drug, within 48 hours prior to administration of the study medication;
10. With special dietary requirements, or cannot accept a uniform diet；
11. Use of strong or moderate CYP3A inhibitors (e.g., clarithromycin, telithromycin, ketoconazole, itraconazole and nefazodone, etc.) or strong CYP3A4 inducers (e.g., rifampicin, efavirenz, carbamazepine, phenobarbital, phenytoin, pioglitazone, St. John's wort, and glucocorticoids, etc.) within 28 days or 5 half-lives (whichever is longer) before screening；
12. Use of strong or moderate UGT1A inhibitors (e.g., silybin, ritonavir, atazanavir, quinidine, diclofenac, mycophenolic acid, and osimertinib, etc.) or strong UGT1A1 inducers (e.g., rifampicin, carbamazepine, phenobarbital, and phenytoin, etc.) within 28 days or 5 drug half-lives (whichever is longer) before screening;
13. Use of any prescription drugs, over-the-counter drugs or Chinese (herbal) medicines within 14 days or 5 drug half-lives (whichever is longer) prior to screening；
14. Vaccination (e.g., SARS-CoV-2 virus vaccine, and hepatitis B virus vaccine, etc.) within 1 month before screening, and are not suitable for enrollment as assessed by the investigator；
15. Positive for hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody, or Tponema pallidum (Tp) antibody at screening；
16. History of substance abuse within 5 years prior to screening, or positive urine drug screen at screening；
17. Females who are pregnant or lactating at the time of screening, or have a positive blood pregnancy test (for WOCBP only)；
18. Participation in any interventional clinical trials, including drugs, vaccines, or devices, etc., within 3 months prior to screening,；
19. It is not suitable for a participant to participate in this trial in the judgment of the investigator.

Where this trial is running

Beijing

• Beijing Ditan Hospital Capital Medical University — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Fujie Zhang, M.D., Ph.D. — Beijing Ditan Hospital
• Study coordinator: Hong Qin, M.D., Ph.D.

Conditions Healthy Adult Participants