A Phase 1 Study of ANJ900 Chinese Healthy Subjects

A Phase 1 Study to Investigate the Pharmacokinetics of ANJ900 (Metformin Hydrochloride Delayed-release Tablets) and the Effect of Food on the Pharmacokinetics of ANJ900 in Chinese Healthy Subjects

This will be a Phase 1, randomised, open label, 3 way crossover study in healthy male and female Chinese subjects. Subjects will participate in 3 treatment periods and will be randomised in a 1:1:1 ratio to 1 of 3 treatment sequences. There will be a washout period of 7 days between doses.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: ANJ900; Drug: Metformin IR

Detailed Description

This will be a Phase 1, randomised, open label, 3 way crossover study in healthy male and female Chinese subjects. Subjects will participate in 3 treatment periods and will be randomised in a 1:1:1 ratio to 1 of 3 treatment sequences. There will be a washout period of 7 days between doses.

All subjects will receive each of the following treatments:

• Treatment 1: A single dose of 1800 mg ANJ900 in the fasted state.
• Treatment 2: A single dose of 1800 mg ANJ900 in the fed state.
• Treatment 3: A single dose of 1000 mg metformin IR in the fasted state. Potential subjects will be screened to assess their eligibility to enter the study within 14 days prior to the first dose administration. Subjects will be admitted into the study site on Days 1, 7, and 14 and will be confined to the study site until discharge on Days 3, 10, and 17 respectively.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Haidan
    • Beijing, Haidan, China
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Chinese males or females between 18 and 65 years of age, inclusive.
2. Body mass index between 18.5 and 28.0 kg/m2, inclusive, with a body weight >50 kg (males) or >45 kg (females).
3. In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG (including heart rate ≥50 bpm, PR interval <200 ms, and QRS duration <120 ms), vital signs measurements (systolic blood pressure ≥90 and <140 mmHg and diastolic blood pressure ≥50 and <90 mmHg), and clinical laboratory evaluations at screening and Day -1 as assessed by the investigator (or designee).
4. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in Appendix 3.
5. Able to comprehend and willing to sign an ICF, remain at the study site, and to abide by the study restrictions.

Exclusion Criteria:

1. Significant history or clinical manifestation of any metabolic, allergic (eg, asthma, urticaria, eczema dermatitis), dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
2. Malignancy within 5 years (except basal cell skin carcinoma).

3. History of a clinically significant disease that affects drug absorption, metabolism, or elimination processes, as determined by the investigator (or designee), including, but not limited to:

   1. inflammatory bowel disease, gastritis, ulcers, bile duct stones, or internal bleeding of the gastrointestinal tract or rectum
   2. gastrointestinal surgery (eg, anastomosis or bowel resection)
   3. pancreatic injury or pancreatitis
   4. urinary tract obstruction or difficulty passing urine.
4. History of hypoglycaemic episodes, severe unconscious hypoglycaemia, or glucose metabolism disorders.
5. History of significant hypersensitivity, intolerance, or allergy to any drug compound (eg, metformin), food, or other substance, unless approved by the investigator (or designee).
6. Active symptoms, or a recent diagnosis of, coronavirus disease-19 (COVID-19).
7. Donation or loss of >500 mL of blood within 4 weeks prior to screening.
8. Receipt of blood products within 8 weeks prior to screening.
9. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months.
10. Poor peripheral venous access or intolerant of venous blood collection.
11. Use or intend to use any prescription medications (with the exception of paracetamol [≤4000 mg/day] or ibuprofen [≤2400 mg/day]) within 4 weeks or 5 half lives, whichever is longer, prior to screening.
12. Use or intend to use any over the counter medications (with the exception of paracetamol [≤4000 mg/day], ibuprofen [≤2400 mg/day], and topical over the counter medications for external use), herbal medications, or food supplements (eg, vitamins or mineral supplements) within 2 weeks or 5 half lives, whichever is longer, prior to screening.
13. Fasting plasma glucose <3.9 mmol/L or >6.1 mmol/L at screening or Day -1.
14. Alanine aminotransferase, aspartate aminotransferase, or direct bilirubin >1.5 × the upper limit of normal at screening or Day -1.
15. Positive hepatitis panel, human immunodeficiency virus test, or syphilis test.
16. History of alcoholism or drug/chemical abuse within 12 months.
17. Alcohol consumption of >21 units per week for males and >14 units for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
18. Have consumed foods and beverages containing caffeine, xanthine, alcohol, or components that affect the absorption, metabolism, and excretion of drugs (eg, grapefruit or Seville oranges) within 48 hours prior to check-in.
19. Have smoked >5 cigarettes or use the equivalent tobacco or nicotine containing products per day in the past 3 months, or are unwilling to abstain from smoking cigarettes or use the equivalent tobacco or nicotine containing products from 48 hours prior to Day -1 until discharge.
20. Are unwilling to abstain from strenuous exercise from 48 hours prior to Day -1 until discharge.
21. Positive alcohol breath test, urine drugs of abuse test, or urine cotinine test.
22. Subjects who, in the opinion of the investigator (or designee), should not participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ANJ900 in the fasted state; Single dose (1800 mg) of ANJ900	Drug: ANJ900; Metformin hydrochloride delayed-release tablets; Other Names: Met DR
Experimental: ANJ900 in the fed state; Single dose (1800 mg) of ANJ900	Drug: ANJ900; Metformin hydrochloride delayed-release tablets; Other Names: Met DR
Active Comparator: Metformin IR in the fasted state; Single dose (1000 mg) of metformin IR	Drug: Metformin IR; metformin hydrochloride; Other Names: Met IR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize the AUC of single oral dose of ANJ900 in healthy Chinese subjects	ANJ900 levels in blood will be collected in serial draws	1 week
Characterize Cmax of a single oral dose of ANJ900 in healthy Chinese subjects	ANJ900 levels in blood will be collected in serial draws	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize the urine excretion from time zero to 24 hours post does of metformin	Urine will be analyzed for ANJ900	1 week
Assess the safety of ANJ900 in healthy Chinese subjects	Adverse events will be collected and reported	3 weeks

Collaborators and Investigators

• Sponsor: Anji Pharma
• Investigators: Principal Investigator: Dongyang Liu, MD, Peking University Third Hospital; Principal Investigator: Haiyan Liu, MD, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: ANJ900D1104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes