Tolerability and Pharmacokinetics of Hypidone Hydrochloride in Healthy Subjects

NCT04598607 | Completed Phase 1

• 2 other identifiers: HYP104-CTP2017ZX09309012
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (4)

• Cmax

  Peak Plasma Concentration

  Day 1-11

• Tmax

  Time to Peak Plasma Concentration

  Day 1-11

• AUC

  Area under the plasma concentration versus time curve

  Day 1-11

• T1/2

  half-life

  Day 1-11

Secondary Outcomes (5)

• Percentage of subjects with treatment-emergent adverse events(TEAE)

  Up to Day 15

• Percentage of subjects with abnormal Laboratory values

  Up to Day 15

• Percentage of subjects with abnormal Physical examinations results

  Up to Day 15

• Percentage of subjects with abnormal Vital signs results

  Up to Day 15

• Percentage of subjects with abnormal ECG(12-lead Electrocardiogram) results

  Up to Day 15

Study Arms (6)

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.

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.

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.

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.

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.

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.

Drug: Placebo

Interventions

Hypidone Hydrochloride tablets DRUG

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.

Also known as: HHT101

Hypidone Hydrochloride 100mg; Hypidone Hydrochloride 60mg; Hypidone Hydrochloride 80mg

Placebo DRUG

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.

Placebo 100mg; Placebo 60mg; Placebo 80mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: The ratio of male and female is 1:1.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese healthy subjects, male to female ratio is 1:1;
• ≤ 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Zhejiang Huahai Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

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

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 22, 2020
• Study Start: October 30, 2020
• Primary Completion: January 11, 2021
• Study Completion: January 15, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

CN (1)