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Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subjects

Primary Purpose

Depression

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Ammoxetine Hydrochloride Enteric-coated Tablets

placebo enteric-coated tablets

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Males and females age 18-45 years
Body weight ≥ 45kg (female) or 50Kg (male), 18 ≤ BMI ≤ 26
Vital signs, physical examinations and laboratory tests and other tests prove participants are healthy
Sign the informed consent form voluntarily and cooperate voluntarily to complete the test

Exclusion Criteria:

Allergens (allergic to 2 or more drugs, food or pollen)
comorbid illness (mental illness, liver and kidney disease, gastrointestinal diseases, nervous system disease, or other systemic diseases)
have Clinically significant abnormal screening laboratory values.
Systolic pressure > 140mmHg or diastolic > 90 mmHg
Postural hypotension (systolic blood pressure drop by 20mmHg or diastolic blood pressure drop by 10mmHg after standing position)
The QTc period ≥ 450ms (male) or 470ms (female) or has a history of QTc extension
Smoking or alcohol consumption (14 units per week in the previous 4 weeks : 1 unit = beer 285mL, or 25mL of spirits, or 150 mL of wine; Daily smoking ≥ 5) or abusing in past year of drug and other substance
Have donated blood > 400 ml within 8 weeks prior to screening
Participated in other clinical trials within 3 months prior to screening
Intaked too much caffeinated beverage or food within 4 weeks prior to screening. such as: Coffee, tea, chocolate, cola, red bull (no more than 6 units per day). 1 unit of caffeine = 1 cup of coffee (177.4 mL) = 2 pots of cola (354.9 mL) = 1 cup of tea (354.9 mL) = 1/2 cup energy drink = 85g chocolate
Have taken drugs that changed liver enzyme activity, such as dexamethasone, ketoconazole, rifampicin and omeprazole, were used within 4 weeks prior to screening
Have taken prescription drugs and OTC (except for the occasional use of acetaminophen and nasal sprays), herbs vitamins or minerals within 4 weeks prior to screening. The interval from prior treatment to screening should be at least 5 half-lives metablism which subjected to the longer half-life
Using any psychotropic drug or psychoactive substance
Women were screened for positive blood pregnancy
The subjects and their partners were not willing to take contraceptives during trial and six months after the study
Have a donor plan recently
Have participated in this trial
The researchers believe that anyone who is unfit to participate in this test will be involved

Sites / Locations

Sichuan huaxi hospital 1 ward.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ammoxetine Hydrochloride Enteric-coated Tablets

Placebo Enteric-coated Tablets

Arm Description

There will be 7 ascending cohorts . Each cohort will be administered in different dose once for 7 days.

There will be 7 ascending cohorts. placebo enteric-coate tablets to mimic Ammoxetine Hydrochloride Enteric-coated tablets.

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events

Incidence of Adverse Events that researchers determined clinical significance

Secondary Outcome Measures

Pharmacokinetics of blood sample

changes in blood concentration

Mass balance

the metabolite analysis in sample of plasma, urine and fecal.

Pharmacokinetics of urine sample

changes in urine concentration

Full Information

NCT ID

NCT03456388

First Posted

August 9, 2017

Last Updated

February 18, 2019

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03456388

Brief Title

Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subjects

Official Title

A Phase ⅠAscending Single-dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

October 30, 2017 (Actual)

Primary Completion Date

July 11, 2018 (Actual)

Study Completion Date

February 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study evaluates the safety, tolerability and pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese heathy subjects. Part of the participants will receive Ammoxetine Hydrochloride Enteric-coated Tablets, while the other part will receive placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ammoxetine Hydrochloride Enteric-coated Tablets

Arm Type

Experimental

Arm Description

There will be 7 ascending cohorts . Each cohort will be administered in different dose once for 7 days.

Arm Title

Placebo Enteric-coated Tablets

Arm Type

Active Comparator

Arm Description

There will be 7 ascending cohorts. placebo enteric-coate tablets to mimic Ammoxetine Hydrochloride Enteric-coated tablets.

Intervention Type

Drug

Intervention Name(s)

Ammoxetine Hydrochloride Enteric-coated Tablets

Intervention Description

There will be 7 ascending cohorts. The first cohort will be administered 2.5 mg once. The second cohort will be administered 7.5 mg. The third cohort will be administered 15 mg once. The forth cohort will be administered 30 mg once. The fifth cohort will be administered 45 mg once. The sixth cohort will be administered 65 mg once.The seventh cohort will be administered 100 mg once. The results of each dose group were shown to be safe and tolerable, and then the next dose group was tested.

Intervention Type

Drug

Intervention Name(s)

placebo enteric-coated tablets

Intervention Description

Primary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events

Description

Incidence of Adverse Events that researchers determined clinical significance

Time Frame

8 days

Secondary Outcome Measure Information:

Title

Pharmacokinetics of blood sample

Description

changes in blood concentration

Time Frame

8 days

Title

Mass balance

Description

the metabolite analysis in sample of plasma, urine and fecal.

Time Frame

8 days

Title

Pharmacokinetics of urine sample

Description

changes in urine concentration

Time Frame

8days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males and females age 18-45 years Body weight ≥ 45kg (female) or 50Kg (male), 18 ≤ BMI ≤ 26 Vital signs, physical examinations and laboratory tests and other tests prove participants are healthy Sign the informed consent form voluntarily and cooperate voluntarily to complete the test Exclusion Criteria: Allergens (allergic to 2 or more drugs, food or pollen) comorbid illness (mental illness, liver and kidney disease, gastrointestinal diseases, nervous system disease, or other systemic diseases) have Clinically significant abnormal screening laboratory values. Systolic pressure > 140mmHg or diastolic > 90 mmHg Postural hypotension (systolic blood pressure drop by 20mmHg or diastolic blood pressure drop by 10mmHg after standing position) The QTc period ≥ 450ms (male) or 470ms (female) or has a history of QTc extension Smoking or alcohol consumption (14 units per week in the previous 4 weeks : 1 unit = beer 285mL, or 25mL of spirits, or 150 mL of wine; Daily smoking ≥ 5) or abusing in past year of drug and other substance Have donated blood > 400 ml within 8 weeks prior to screening Participated in other clinical trials within 3 months prior to screening Intaked too much caffeinated beverage or food within 4 weeks prior to screening. such as: Coffee, tea, chocolate, cola, red bull (no more than 6 units per day). 1 unit of caffeine = 1 cup of coffee (177.4 mL) = 2 pots of cola (354.9 mL) = 1 cup of tea (354.9 mL) = 1/2 cup energy drink = 85g chocolate Have taken drugs that changed liver enzyme activity, such as dexamethasone, ketoconazole, rifampicin and omeprazole, were used within 4 weeks prior to screening Have taken prescription drugs and OTC (except for the occasional use of acetaminophen and nasal sprays), herbs vitamins or minerals within 4 weeks prior to screening. The interval from prior treatment to screening should be at least 5 half-lives metablism which subjected to the longer half-life Using any psychotropic drug or psychoactive substance Women were screened for positive blood pregnancy The subjects and their partners were not willing to take contraceptives during trial and six months after the study Have a donor plan recently Have participated in this trial The researchers believe that anyone who is unfit to participate in this test will be involved

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qi Shen

Organizational Affiliation

Sichuan huaxi hospital 1 ward.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sichuan huaxi hospital 1 ward.

City

Chengdu

State/Province

Si Chuan

ZIP/Postal Code

610000

Country

China

12. IPD Sharing Statement

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Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subjects

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