DepressionPhase 1NCT03456388
Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subjects
A Phase 1 study testing Ammoxetine Hydrochloride Enteric-coated Tablets in people with Depression, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial 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. 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
- 58 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2017to 15 Feb 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 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- 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 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 tabletsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ammoxetine Hydrochloride Enteric-coated Tablets | Experimental | There will be 7 ascending cohorts . Each cohort will be administered in different dose once for 7 days. Receives: 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. 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 Events
Incidence of Adverse Events that researchers determined clinical significance
Measured: 8 days
Secondary outcomes (3)
Pharmacokinetics of blood sample
changes in blood concentration
Measured: 8 days
Mass balance
the metabolite analysis in sample of plasma, urine and fecal.
Measured: 8 days
Pharmacokinetics of urine sample
changes in urine concentration
Measured: 8days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start30 Oct 2017
- Primary completion11 Jul 2018
- Study completion15 Feb 2019
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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qi Shen, Principal investigator, Sichuan huaxi hospital 1 ward.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456388
- Sponsor's protocol ID
- AMXT201701/PRO
- Status last verified
- Aug 2018
- First submitted
- 9 Aug 2017
- Last updated
- 20 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03456388
- Acronym / sponsor ID
- AMXT201701/PRO
- Conditions
- Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 11 Jul 2018 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 7 Mar 2018 (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 heathy subjects. Part of the participants will receive Ammoxetine Hydrochloride Enteric-coated Tablets, while the other part will receive placebo.
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 TabletsThere will be 7 ascending cohorts . Each cohort will be administered in different dose once for 7 days. |
| Placebo Enteric-coated Tablets | Active comparator | Drug: placebo enteric-coated tabletsThere will be 7 ascending cohorts. placebo enteric-coate tablets to mimic Ammoxetine Hydrochloride 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 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. | Drug | Ammoxetine Hydrochloride Enteric-coated Tablets |
| placebo enteric-coated tabletsThere 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. | Drug | Placebo Enteric-coated Tablets |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 8 days
Incidence of Adverse Events that researchers determined clinical significance
3 secondary outcomes
Pharmacokinetics of blood sample
Time frame: 8 days
Mass balance
Time frame: 8 days
Pharmacokinetics of urine sample
Time frame: 8days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
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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.
Qi Shen principal investigator
Sichuan huaxi hospital 1 ward.
1 site in 1 country: see every site and its status.
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. at 1 site in China.
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: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Events (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2019.