Open-label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of [14C]-20 mg/100 μCi Anaprazole Sodium Enteric-coated Capsule in Healthy Adult Male Subjects

NCT04476394 | Unknown Phase 1

• 1 other identifier: 3571-MB-1005
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single oral dose of \[14C\]-20 mg/100 μCi Anaprazole Sodium enteric-coated capsule in healthy adult male subjects. Whole blood, plasma samples will be collected at hour 0 pre-dose and 1，2，3，4，5，6，8，12，24，48，72，96，120，144，168 hours post-dose (tentative, adjusted according to plasma drug concentration); urine samples will be collected at hour 24 pre-dose and 0-4，4-8，8-12，12-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose (tentative, adjusted according to sample recovery rate) ; fecal samples will be collected at hour 24 pre-dose and 0-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose (tentative, adjusted according to sample recovery rate) following the start of administration to measure total radioactivity and plasma drug concentrations.

Conditions

Healthy Male Volunteers

Outcome Measures

Primary Outcomes (8)

• Cmax of Anaprazole according to total radioactivity concentration equivalents in whole blood and plasma

  Cmax is the peak plasma concentration

  Hour 0 pre-dose and 1，2，3，4，5，6，8，12，24，48，72，96，120，144，168 hours post-dose (tentative, adjusted according to plasma drug concentration)

• Tmax of Anaprazole according to total radioactivity concentration equivalents in whole blood and plasma

  Tmax is the time to maximum plasma concentration

  Hour 0 pre-dose and 1，2，3，4，5，6，8，12，24，48，72，96，120，144，168 hours post-dose (tentative, adjusted according to plasma drug concentration)

• AUC of Anaprazole according to total radioactivity concentration equivalents in whole blood and plasma

  AUC is area under the plasma concentration-time curve

  Hour 0 pre-dose and 1，2，3，4，5，6，8，12，24，48，72，96，120，144，168 hours post-dose (tentative, adjusted according to plasma drug concentration)

• Cumulative excretion and cumulative excretion rate in urine

  Sum of the percent of the total radioactivity recovered in urine relative to the administered radioactivity dose

  Hour 24 pre-dose and 0-4，4-8，8-12，12-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose (tentative, adjusted according to sample recovery rate)

• Cumulative excretion and cumulative excretion rate in feces

  Sum of the percent of the total radioactivity recovered in feces relative to the administered radioactivity dose

  Hour 24 pre-dose and 0-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose (tentative, adjusted according to sample recovery rate)

• Radioactivity spectrum indentification of metabolites in plasma

  plasma concentration of metabolites

  Hour 0 pre-dose and 1，2，3，4，5，6，8，12，24，48，72，96，120，144，168 hours post-dose (tentative, adjusted according to plasma drug concentration)

• Radioactivity spectrum indentification of metabolites in urine

  Concentration of metabolites in urine

  Hour 24 pre-dose and 0-4，4-8，8-12，12-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose (tentative, adjusted according to sample recovery rate)

• Concentration of metabolites in feces

  Sum of the percent of the total radioactivity recovered in feces relative to the administered radioactivity dose

  Hour 24 pre-dose and 0-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose (tentative, adjusted according to sample recovery rate)

Study Arms (1)

1

EXPERIMENTAL

Administered orally once

Drug: [14C]-Anaprazole Sodium enteric-coated capsule

Interventions

[14C]-Anaprazole Sodium enteric-coated capsule DRUG

\[14C\]-Anaprazole Sodium enteric-coated capsule

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject is a Chinese adult male, aged 18 to 45 years, inclusive.
• The subject weighed at least 50.0 kg and had a body mass index (BMI) between 19.0 kg/m\^2 and 26.0 kg/m\^2, inclusive.
• \. Participants with evaluations of vital signs, physicial examination results,clinical laboratory and ECG testing outside the reference range that are deemed not clinically significant at investigator discretion at screening.
• The subject with childbearing potential agrees that the subject and his sexual partner use adequate contraception from signing of informed consent throughout the duration of the study and for 6 months after study completion.
• The subject is capable of understanding and complying with protocol requirements, and signed and dated a written informed consent form voluntarily

You may not qualify if:

• Has clinical significant drug allergy or allergic disease history(Such as asthma, urticaria, eczema dermatitis, etc), or has hypersensitivity or allergy to investigatory drugs or related supplements；
• Has clinical significant ECG abnormal history or family history of long QT syndrome(Grandparents, parents and siblings)
• Any disease or medical history that may significantly affect the absorption, distribution, metabolism, and excretion of drugs, or any condition that may pose a hazard to the subject. Such as:
• Inflammatory bowel disease, gastric ulcer, duodenal ulcer, gastrointestinal / rectal bleeding, persistent nausea, or other clinically significant gastrointestinal abnormalities;
• Has suffered from gastrointestinal diseases or complications that may affect the absorption of drugs (ie: malabsorption, gastroesophageal reflux, peptic ulcer, erosive esophagitis, frequent heartburn) within 6 months before screening or had history of gastrointestinal surgery (for example: gastrectomy, gastrointestinal anastomosis, intestinal resection, gastric bypass, gastric segmentation or gastric banding, cholecystectomy, except for appendicitis surgery and proctectomy);
• Evidence of liver disease or clinically impaired liver function at the time of screening (eg AST, ALT or total bilirubin\> 1.5 times ULN);
• A history or evidence of nephropathy or renal insufficiency at the time of screening, showing clinically significant abnormality of creatinine or abnormal urine composition (such as proteinuria, creatinine\> 176.8 umol / L, etc.)
• Has difficulty swallowing oral preparations.
• Thyroid stimulating hormone (TSH)\> ULN; or serum free triiodothyronine (FT3)\> ULN; or serum free thyroxine (FT4)\> ULN at the time of screening;
• \. Frequent smokers and alcoholics within 3 months before screening (smoke more than 5 cigarettes / day, drink more than 21 units of alcohol per week, 1 unit = 360 mL beer or 45 mL liquor or 150 mL wine), or can't stop using any tobacco products, and alcohol intake during the study period ; or those who have a positive alcohol breath test before enrollment;
• \. Has received any investigational compound (including post-marketing investigational drugs) or participated in clinical trials of any drugs /devices within 3 months before screening;
• \. A history of drug abuse within 12 months before screening or a positive urine test result at screening;
• \. Has used any prescription drugs, non-prescription drugs (including chemical drugs, vitamin drugs, Chinese herbal medicines, etc.) within 4 weeks before administration of investigational drugs;
• \. Has taken foods that affect CYP3A4 (such as grapefruit or beverages containing grapefruit) within 2 weeks before administration of investigational drugs;
• \. Human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis C antibody, and Treponema pallidum specific antibody test results were positive at screening;

Sponsors & Collaborators

• Sihuan Pharmaceutical Holdings Group Ltd.: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 20, 2020
• Study Start: August 3, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: July 20, 2020

Record last verified: 2020-04