Major Depressive DisorderPhase 1NCT04598607

Tolerability and Pharmacokinetics of Hypidone Hydrochloride in Healthy Subjects

A Phase 1 study testing Hypidone Hydrochloride tablets in people with Major Depressive Disorder, run by Zhejiang Huahai Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will investigate the tolerability and pharmacokinetics of Hypidone Hydrochloride by multiple doses in 36 healthy male and female subjects who are of 18 to 55 years old. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Major Depressive Disorder
What is being tested?: Hypidone Hydrochloride 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: 1 siteChina
Study dates: 30 Oct 2020to 15 Jan 2021
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Chinese healthy subjects, male to female ratio is 1:1;
18 ≤ age ≤55;
Female body weight is not less than 45kg, male body weight is not less than 50kg, BMI is between 18.5~28.0 kg/m2 (including upper and lower limits);
Understand and sign informed consent, and participate in clinical trials voluntarily.

Who cannot join

Those who have a history of major diseases such as cardiovascular system, respiratory system, liver, kidney, endocrine system, digestive system, blood and lymphatic system, immune system, nervous system, skeletal system and psychiatry, and who are judged unfit to participate in this study;
Any condition or condition that may significantly affect drug absorption, distribution, metabolism, and excretion, such as a history of gastrointestinal surgery (gastrectomy, gastroenterostomy, enterectomy, etc.);
General physical examination, vital signs and other abnormalities judged by clinicians as clinically significant;
resting pulse rate <55 times/min or >100 times/min;Sitting systolic pressure <90mmHg or >140mmHg, diastolic pressure <60mmHg or >90mmHg;
The laboratory examination indicates that the subject has abnormalities that the researcher has determined to be clinically significant;
ALT or Cr and BUN exceeding the upper limit of normal value;Urine protein test results "++" or above;

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Serum virology test (HBs antigen, HCV antibody, syphilis serum reaction (Trust test) and HIV antibody test) with positive results;
Abnormal electrocardiogram (ECG) at screening stage is of clinical significance, such as QTc interval ≥450ms in men and QTc interval ≥470ms in women, and the researchers think it is not suitable to be included;
patients who had taken any prescription drugs, non-prescription drugs, Chinese herbs, vitamins and other dietary supplements in the two weeks prior to enrollment, and the researchers believe that this situation may affect the evaluation results of this study.
Those who have taken food or drink (such as grapefruit) containing enzymes that can induce or inhibit liver metabolism within 1 week before starting the administration of the test;
A history of severe allergy or has a history of allergy to two or more foods or drugs;
Subjects with a history of smoking 2 weeks before the screening period or subject with positive urine cotinine test during the admission review period;
A history of alcohol abuse and consume an average of more than 14 units of alcohol per week (1 unit =285ml beer or 25ml spirits or 150ml wine), or during the study subjects were unable to avoid alcohol consumption within 24 hours before and during the study period or alcohol breath test positive;
A history of drug abuse or drug abuse, or those with positive urine drug screening;
Pregnant or lactating women;
The subject or his/her spouse has a family planning plan within the next 6 months of the last use of the drug, and is unable to use the contraceptive method approved by the Study during the study period as directed by the investigator;
Those who had donated blood or lost blood ≥400mL in the 3 months before screening, and those who had donated blood ≥200mL in the 1 month before screening or had a history of component donation;
it is impossible to avoid using caffeinated drinks, strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, and excretion within 24 hours before and during the trial;
Subjects who have participated in or are participating in other experimental drugs or unlisted drug trials within 3 months prior to screening;
Persons directly related to this clinical trial;
Subjects who, in the opinion of the investigator, have other factors that are not appropriate to participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030

Other trials in China

About this study

Official title: A Multiple-Dose Study to Evaluate the Tolerability and Pharmacokinetics of Hypidone Hydrochloride Tablets in Chinese Healthy Subjects

This study will investigate the tolerability and pharmacokinetics of Hypidone Hydrochloride by multiple doses in 36 healthy male and female subjects who are of 18 to 55 years old.

Read the detailed description

This is a double-blind, placebo-controlled, randomized, multiple-dose, single center study. 36 male and female healthy subjects will be enrolled in this study. Within 14 days prior to study drug administration, subjects will be screened based on the inclusion and exclusion criteria. The study will be performed in 3 groups of 12 subjects each. In each group of 12 subjects, 10 subjects will be randomly assigned to receive Hypidone Hydrochloride and 2 subjects to receive matching placebo.

Conditions: Major Depressive Disorder
Being tested: Hypidone Hydrochloride tablets, Placebo
Medical subject headings: Depressive Disorder, Major

What participants receive

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

Hypidone Hydrochloride tabletsDrug
Also called HHT101
30mg(10mg×3), 40mg(10mg×4) or 50mg(10mg×5) Hypidone Hydrochloride tablets will be given orally once on day 1, day 9 and twice a day on day 3~8.
PlaceboDrug
3, 4 or 5 tablets of placebo will be given orally once on day 1, day 9 and twice a day on day 3~8.

Study groups in NCT04598607
Study group	Role	What they receive
Hypidone Hydrochloride 60mg	Experimental	30mg(10mg×3) Hypidone Hydrochloride tablets will be given orally once on day 1, day 9 and twice a day on day 3~8. Receives: Drug: Hypidone Hydrochloride tablets
Hypidone Hydrochloride 80mg	Experimental	40mg(10mg×4) Hypidone Hydrochloride tablets will be given orally once on day 1, day 9 and twice a day on day 3~8. Receives: Drug: Hypidone Hydrochloride tablets
Hypidone Hydrochloride 100mg	Experimental	50mg(10mg×5) Hypidone Hydrochloride tablets will be given orally once on day 1, day 9 and twice a day on day 3~8. Receives: Drug: Hypidone Hydrochloride tablets
Placebo 60mg	Placebo comparator	3 tablets of placebo will be given orally once on day 1, day 9 and twice a day on day 3~8. Receives: Drug: Placebo
Placebo 80mg	Placebo comparator	4 tablets of placebo will be given orally once on day 1, day 9 and twice a day on day 3~8. Receives: Drug: Placebo
Placebo 100mg	Placebo comparator	5 tablets of placebo will be given orally once on day 1, day 9 and twice a day on day 3~8. Receives: Drug: Placebo

What is being measured

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

Cmax
Peak Plasma Concentration
Measured: Day 1-11
Tmax
Time to Peak Plasma Concentration
Measured: Day 1-11
AUC
Area under the plasma concentration versus time curve
Measured: Day 1-11
T1/2
half-life
Measured: Day 1-11

Secondary outcomes (5)

Percentage of subjects with treatment-emergent adverse events(TEAE)
Clinical significant Abnormal of Laboratory valuse, physical examination results, vital signs and ECG results will be recorded as TEAE.
Measured: Up to Day 15
Percentage of subjects with abnormal Laboratory values
Laboratory tests including Hematology, Biochemistry and Urinalysis.
Measured: Up to Day 15
Percentage of subjects with abnormal Physical examinations results
Physical examinations including Head and face, skin system, lymph nodes, eyes, ear, nose and throat, mouth, respiratory system, abdomen, cardiovascular system, musculoskeletal and nervous system.
Measured: Up to Day 15
Percentage of subjects with abnormal Vital signs results
Vital signs including sitting blood pressure, pulse rate and ear temperature.
Measured: Up to Day 15
Percentage of subjects with abnormal ECG(12-lead Electrocardiogram) results
ECG tests including heart rates, PR interval, QT interval, corrected QT interval.
Measured: Up to Day 15

Timeline

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

30 Oct 202015 Jan 2021

First posted22 Oct 2020
Study start30 Oct 2020
Primary completion11 Jan 2021
Study completion15 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
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: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04598607
Sponsor's protocol ID: HYP104-CTP
Other IDs: 2017ZX09309012
Status last verified: Aug 2021
First submitted: 13 Oct 2020
Last updated: 25 Aug 2021
Results posted: No
Data monitoring committee: 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?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2021. 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 Hypidone Hydrochloride Tablets in Chinese Healthy Subjects
ClinicalTrials.gov ID: NCT04598607
Acronym / sponsor ID: HYP104-CTP
Conditions: Major Depressive Disorder
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Zhejiang Huahai Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 30 Oct 2020 (actual)
Primary completion: 11 Jan 2021 (actual)
Study completion: 15 Jan 2021 (actual)
First posted: 22 Oct 2020 (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 will investigate the tolerability and pharmacokinetics of Hypidone Hydrochloride by multiple doses in 36 healthy male and female subjects who are of 18 to 55 years old.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Hypidone Hydrochloride 60mg	Experimental	Drug: Hypidone Hydrochloride tablets30mg(10mg×3) Hypidone Hydrochloride tablets will be given orally once on day 1, day 9 and twice a day on day 3~8.
Hypidone Hydrochloride 80mg	Experimental	Drug: Hypidone Hydrochloride tablets40mg(10mg×4) Hypidone Hydrochloride tablets will be given orally once on day 1, day 9 and twice a day on day 3~8.
Hypidone Hydrochloride 100mg	Experimental	Drug: Hypidone Hydrochloride tablets50mg(10mg×5) Hypidone Hydrochloride tablets will be given orally once on day 1, day 9 and twice a day on day 3~8.
Placebo 60mg	Placebo comparator	Drug: Placebo3 tablets of placebo will be given orally once on day 1, day 9 and twice a day on day 3~8.
Placebo 80mg	Placebo comparator	Drug: Placebo4 tablets of placebo will be given orally once on day 1, day 9 and twice a day on day 3~8.
Placebo 100mg	Placebo comparator	Drug: Placebo5 tablets of placebo will be given orally once on day 1, day 9 and twice a day on day 3~8.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Chinese healthy subjects, male to female ratio is 1:1;
18 ≤ age ≤55;
Female body weight is not less than 45kg, male body weight is not less than 50kg, BMI is between 18.5~28.0 kg/m2 (including upper and lower limits);
Understand and sign informed consent, and participate in clinical trials voluntarily.

Key exclusion criteria (21 listed)

Those who have a history of major diseases such as cardiovascular system, respiratory system, liver, kidney, endocrine system, digestive system, blood and lymphatic system, immune system, nervous system, skeletal system and psychiatry, and who are judged unfit to participate in this study;
Any condition or condition that may significantly affect drug absorption, distribution, metabolism, and excretion, such as a history of gastrointestinal surgery (gastrectomy, gastroenterostomy, enterectomy, etc.);
General physical examination, vital signs and other abnormalities judged by clinicians as clinically significant;
resting pulse rate <55 times/min or >100 times/min;Sitting systolic pressure <90mmHg or >140mmHg, diastolic pressure <60mmHg or >90mmHg;
The laboratory examination indicates that the subject has abnormalities that the researcher has determined to be clinically significant;

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
Hypidone Hydrochloride tabletsAlso: HHT10130mg(10mg×3), 40mg(10mg×4) or 50mg(10mg×5) Hypidone Hydrochloride tablets will be given orally once on day 1, day 9 and twice a day on day 3~8.	Drug	Hypidone Hydrochloride 100mg, Hypidone Hydrochloride 60mg, Hypidone Hydrochloride 80mg
Placebo3, 4 or 5 tablets of placebo will be given orally once on day 1, day 9 and twice a day on day 3~8.	Drug	Placebo 100mg, Placebo 60mg, Placebo 80mg

Primary outcome

Cmax
Time frame: Day 1-11
Peak Plasma Concentration
Tmax
Time frame: Day 1-11
Time to Peak Plasma Concentration
AUC
Time frame: Day 1-11
Area under the plasma concentration versus time curve
T1/2
Time frame: Day 1-11
half-life

5 secondary outcomes

Percentage of subjects with treatment-emergent adverse events(TEAE)
Time frame: Up to Day 15
Percentage of subjects with abnormal Laboratory values
Time frame: Up to Day 15
Percentage of subjects with abnormal Physical examinations results
Time frame: Up to Day 15
Percentage of subjects with abnormal Vital signs results
Time frame: Up to Day 15
Percentage of subjects with abnormal ECG(12-lead Electrocardiogram) results
Time frame: Up to Day 15

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 25 Aug 2021.

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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.

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 Hypidone Hydrochloride tablets in people with Major Depressive Disorder, run by Zhejiang Huahai Pharmaceutical 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 21 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 25 Aug 2021. 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. 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?

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?

Cmax (time frame: Day 1-11). 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 NCT04598607.

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 25 Aug 2021.