Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subjects

NCT03456388 | Completed Phase 1

• 1 other identifier: AMXT201701/PRO
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Incidence of Adverse Events that researchers determined clinical significance

  8 days

Secondary Outcomes (3)

• Pharmacokinetics of blood sample

  8 days

• Mass balance

  8 days

• Pharmacokinetics of urine sample

  8days

Study Arms (2)

Ammoxetine Hydrochloride Enteric-coated Tablets

EXPERIMENTAL

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

Drug: Ammoxetine Hydrochloride Enteric-coated Tablets

Placebo Enteric-coated Tablets

ACTIVE COMPARATOR

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

Drug: placebo enteric-coated tablets

Interventions

Ammoxetine Hydrochloride Enteric-coated Tablets DRUG

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.

Ammoxetine Hydrochloride Enteric-coated Tablets

placebo enteric-coated tablets DRUG

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.

Placebo Enteric-coated Tablets

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Sichuan huaxi hospital 1 ward.

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Qi Shen

  Sichuan huaxi hospital 1 ward.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: March 7, 2018
• Study Start: October 30, 2017
• Primary Completion: July 11, 2018
• Study Completion: February 15, 2019
• Last Updated: February 20, 2019

Record last verified: 2018-08

Locations

CN (1)