DepressionPhase 1NCT03850834

Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subject

A Phase 1 study testing Ammoxetine Hydrochloride Enteric-coated Tablets in people with Depression, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This study evaluates the safety, tolerability and pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese healthy subjects Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Depression
What is being tested?: Ammoxetine Hydrochloride Enteric-coated Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: No sites listed yet
Study dates: 10 Mar 2019to 31 Oct 2019
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 18Show fewer

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 or lost blood 400 ml within 8 weeks prior to screening
Participated in other clinical trials within 3 months prior to screening
Intakes 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 halflife
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

About this study

Official title: A Multiple-dose Study to Evaluate the Tolerability and Pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese Healthy Subjects

This study evaluates the safety, tolerability and pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese healthy subjects

Conditions: Depression
Being tested: Ammoxetine Hydrochloride Enteric-coated Tablets, placebo enteric-coated tablets
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ammoxetine Hydrochloride Enteric-coated TabletsDrug
There will be 3 ascending cohorts. The cohorts will be administered 15, 30, 45 mg q12h for 15 times. The results of each dose group were shown to be safe and tolerable, and then the next dose group was tested
placebo enteric-coated tabletsDrug
There will be 3 ascending cohorts. The cohorts will be administered 15, 30, 45 mg q12h for 15 times. The results of each dose group were shown to be safe and tolerable, and then the next dose group was tested

Study groups in NCT03850834
Study group	Role	What they receive
Ammoxetine Hydrochloride Enteric-coated Tablets	Experimental	Not described Receives: Drug: Ammoxetine Hydrochloride Enteric-coated Tablets
Placebo Enteric-coated Tablets	Placebo comparator	Not described Receives: Drug: placebo enteric-coated tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Treatment-Emergent Adverse Event
Incidence of Adverse Events that researchers determined clinical significance
Measured: 15 days
Area under the plasma concentration time curve (AUC)
The pharmacokinetics(PK) profile of Ammoxetine Hydrochloride Enteric-coated Tablets
Measured: 11 days
Maximum concentration (Cmax)
The pharmacokinetics(PK) profile of Ammoxetine Hydrochloride Enteric-coated Tablets
Measured: 11 days
Half life Period (t1/2)
The pharmacokinetics(PK) profile of Ammoxetine Hydrochloride Enteric-coated Tablets
Measured: 11 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Mar 201931 Oct 2019

First posted22 Feb 2019
Study start10 Mar 2019 (estimated)
Primary completion31 May 2019 (estimated)
Study completion31 Oct 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 36 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03850834
Sponsor's protocol ID: AMXT201802/PRO
Status last verified: Feb 2019
First submitted: 20 Feb 2019
Last updated: 22 Feb 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multiple-dose Study to Evaluate the Tolerability and Pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese Healthy Subjects
ClinicalTrials.gov ID: NCT03850834
Acronym / sponsor ID: AMXT201802/PRO
Conditions: Depression
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 36 participants (estimated)
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
Study start: 10 Mar 2019 (estimated)
Primary completion: 31 May 2019 (estimated)
Study completion: 31 Oct 2019 (estimated)
First posted: 22 Feb 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study evaluates the safety, tolerability and pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese healthy subjects

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Ammoxetine Hydrochloride Enteric-coated Tablets	Experimental	Drug: Ammoxetine Hydrochloride Enteric-coated Tablets
Placebo Enteric-coated Tablets	Placebo comparator	Drug: placebo enteric-coated tablets

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (18 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ammoxetine Hydrochloride Enteric-coated TabletsThere will be 3 ascending cohorts. The cohorts will be administered 15, 30, 45 mg q12h for 15 times. The results of each dose group were shown to be safe and tolerable, and then the next dose group was tested	Drug	Ammoxetine Hydrochloride Enteric-coated Tablets
placebo enteric-coated tabletsThere will be 3 ascending cohorts. The cohorts will be administered 15, 30, 45 mg q12h for 15 times. The results of each dose group were shown to be safe and tolerable, and then the next dose group was tested	Drug	Placebo Enteric-coated Tablets

Primary outcome

Incidence of Treatment-Emergent Adverse Event
Time frame: 15 days
Incidence of Adverse Events that researchers determined clinical significance
Area under the plasma concentration time curve (AUC)
Time frame: 11 days
The pharmacokinetics(PK) profile of Ammoxetine Hydrochloride Enteric-coated Tablets
Maximum concentration (Cmax)
Time frame: 11 days
The pharmacokinetics(PK) profile of Ammoxetine Hydrochloride Enteric-coated Tablets
Half life Period (t1/2)
Time frame: 11 days
The pharmacokinetics(PK) profile of Ammoxetine Hydrochloride Enteric-coated Tablets

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.

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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ammoxetine Hydrochloride Enteric-coated Tablets in people with Depression, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Event (time frame: 15 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03850834.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.