Single Ascending Dose, Food Effects and Drug-Drug Interactions of ACC017 Tablets in Healthy Adult Participants

Last updated: March 4, 2024
Sponsor: Jiangsu Aidea Pharmaceutical Co., Ltd
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

ACC017 tablets

Emtricitabine and Tenofovir Alafenamide Fumarate Tablets

Clinical Study ID

NCT06278389
ADYY-ACC017-101
CTR20240167
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The objective of this clinical trial is to investigate the safety and tolerability of single ascending dose ACC017 tablets in Chinese healthy adult participants. This study aims to address the following major questions:

  • Recommended dosage for ACC017 tablets used in phase Ib/IIa trial;

  • The pharmacokinetic (PK) characteristics of single dose ACC017 tablets;

  • The effect of food (FE) on the PK of ACC017 tablets;

  • Drug-drug interactions (DDIs) when ACC017 tablets are co-administered with emtricitabine and tenofovir alafenamide fumarate (FTC/TAF) tablets (II).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Volunteering to sign the informed consent and able to follow protocol-definedprocedural 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 spermor egg donation) and agreeing to use effective contraception (including one or morenon-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 studymedication;
  5. No history of significant medical or surgical illness, and normal results on vitalsigns, physical examination, 12-lead electrocardiogram (ECG), laboratory tests, chestX-ray and abdominal ultrasound examination during the screening period, or minordeviations from normal reference values that are not clinically significant in thejudgment of the investigator.

Exclusion

Exclusion Criteria:

  1. Occurrence or persistence of clinically significant abnormal conditions, including butnot limited to cardiovascular, respiratory, gastrointestinal (any history ofgastrointestinal disorders affecting the absorption of medications), urinary,hematologic and lymphatic, endocrine, musculoskeletal, immune, and neuropsychiatricdisorders;
  2. Possible or definite allergic reaction to the study drug, placebo, or any of theexcipients contained, as judged by the investigator, or allergy (multiple drug andfood sensitivities), or a history of allergic disease (e.g., asthma, urticaria, andeczematous 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) orreceipt of blood transfusion within 3 months prior to screening, or planning to donateblood during the trial period;
  5. Dysphagia, or surgery within 6 months prior to screening, or surgery planned duringthe 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, orinability 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 mLof beer, or 45 mL of 40% (alcohol by volume) spirits, or 150 mL of wine) within 3months prior to screening or inability to discontinue use of any alcohol-containingproduct during the trial period, or with a positive breath test for alcohol atscreening;
  8. Excessive consumption of tea, coffee, and/or caffeinated beverages (more than 8 cupson average per day, 1 cup ≈ 250 mL) within 3 months prior to screening, or inabilityto stop consuming tea, coffee, and/or caffeinated beverages during the trial period;
  9. Consumption or drinking of dragon fruit, mango, grapefruit, popcorn, or foods orbeverages prepared from the aforementioned fruits, or foods or beverages containingxanthines, 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 thestudy 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 islonger) before screening;
  12. Use of strong or moderate UGT1A inhibitors (e.g., silybin, ritonavir, atazanavir,quinidine, diclofenac, mycophenolic acid, and osimertinib, etc.) or strong UGT1A1inducers (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) medicineswithin 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 bythe 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 atscreening;
  16. History of substance abuse within 5 years prior to screening, or positive urine drugscreen at screening;
  17. Females who are pregnant or lactating at the time of screening, or have a positiveblood pregnancy test (for WOCBP only);
  18. Participation in any interventional clinical trials, including drugs, vaccines, ordevices, etc., within 3 months prior to screening,;
  19. It is not suitable for a participant to participate in this trial in the judgment ofthe investigator.

Study Design

Total Participants: 52
Treatment Group(s): 2
Primary Treatment: ACC017 tablets
Phase: 1
Study Start date:
January 24, 2024
Estimated Completion Date:
April 23, 2024

Study Description

This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD), two-stage, phase Ia clinical trial in Chinese healthy adults to evaluate the safety, tolerability, PK, FE, and DDIs with FTC/TAF of ACC017 tablets administered as a single dose in healthy participants.

The trial will be divided into two stages: the first stage is a single-center, randomized, double-blind, placebo-controlled SAD study. The study consists of six dose cohorts, namely, 5 mg, 20 mg, 40 mg, 80 mg, 120 mg, and 160 mg cohorts (whether to escalate to the 160 mg cohort will be determined or adjusted if applicable) (D2~D7), and a subsequent discharge visit (D8). Participants will receive a single oral dose of ACC017 tablets or placebo under fasting conditions.

The second stage is a single-center, randomized, open-label FE and DDI study with a tentative dose of 40 mg. The final administered dose will be determined after completion of the SAD study, as assessed by the investigator and the sponsor. Stage 2 is planned to enroll 12 healthy participants (both males and females), who are randomly assigned at a 1:1 ratio to either the fasting-postprandial group (F-P group) or the postprandial-fasting group (P-F group), with 6 participants in each group. Eligible healthy participants are admitted on D-1 and receive a single oral dose of ACC017 tablets on the day of administration of each cycle under the fasting or postprandial condition, with a washout period of 7 days during the two-week period. After completing the second cycle of drug washout, participants are evaluated by the investigator and enter into the DDI study and receive a single oral dose of ACC017 tablets with FTC/TAF tablets under fasting condition.

The study is divided into screening period (no more than 28 days, D-28 to D-1), FE first cycle (D1), washout period A (D2 to D7), FE second cycle (D8), washout period B (D9 to D14), DDI period (D15), wahout period C (D16 to D21), and discharge (D22) visits.

Connect with a study center

  • Beijing Ditan Hospital Affiliated to Capital Medical University

    Beijing, 100015
    China

    Active - Recruiting

  • Beijing Ditan Hospital Capital Medical University

    Beijing, 100015
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.