Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

A Food Effect Study to Assess Pharmacokinetics of Hemay005 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03577626
Recruitment Status : Not yet recruiting
First Posted : July 5, 2018
Last Update Posted : July 5, 2018
Sponsor:
Information provided by (Responsible Party):
Tianjin Hemay Bio-Tech Co., Ltd

Brief Summary:
The purpose of this study is to evaluate the effect of food on the PK of a single dose of 52.5 mg Hemay005 in healthy subjects.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Hemay005 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Open-labeled, Single Dosing Study to Assess Food Effect on the Pharmacokinetics of Hemay005 in Healthy Volunteers
Estimated Study Start Date : October 10, 2018
Estimated Primary Completion Date : November 10, 2018
Estimated Study Completion Date : March 1, 2019

Arm Intervention/treatment
Experimental: Hemay005 Fast Drug: Hemay005
Hemay005 tablets will be taken orally in dose of 52.5mg at fasted dosing on period one followed by fed dosing on period two.

Experimental: Hemay005 Fed Drug: Hemay005
Hemay005 tablets will be taken orally in dose of 52.5mg at fed dosing on period one followed by fasted dosing on period two




Primary Outcome Measures :
  1. Cmax [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8 ]
    Maximum observed plasma concentration

  2. Tmax [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8 ]
    Time of maximum concentration

  3. AUCt [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8 ]
    Area under the plasma concentration-time curve from time zero to the last quantifiable concentration

  4. AUC∞ [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8 ]
    Area under the plasma concentration-time curve from time zero extrapolated to infinity

  5. t1/2 [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8 ]
    Terminal elimination half-life

  6. CL/F [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8 ]
    Apparent total plasma clearance


Secondary Outcome Measures :
  1. Number of participants with adverse events, serious adverse events [ Time Frame: Day 1 up to Day 11±3 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. healthy subjects aged 18 to 60 years, male and female volunteers;
  2. male Bodyweight(BW)≥ 50kg, female Bodyweight(BW)≥ 45kg, Body mass index (BMI) in 18-28 (including upper and lower limit of the range);
  3. All male subjects must agree and commit to the use of a reliable contraceptive regimen(including vasoligation, abstinence, using a condom) for the duration of the study(from screening until 6 months after the last dose), Female participants with a negative pregnancy test (serum) at both the screening visit and at Day-1, Female subjects and female partners of male subjects must agree and commit to the use of a reliable contraceptive regimen ( oral contraceptive medications or non-oral contraceptive medications) for the duration of the study(from screening until 6 months after the last dose);
  4. Ability to understand and be willing to sign a written informed consent before study entry;
  5. Subjects would have good communication with the investigator and could comply with protocol.

Exclusion Criteria:

  1. A history of clinically severe gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease or haematological disorders;
  2. Have a known history of hypersensitivity to any medicine or food, or allergy to the test article or any of the excipient of the test article;
  3. Have a gastrointestinal, hepatic or renal condition that may influence drug absorption or metabolism;
  4. A history of chronic infection (ie, tuberculosis);
  5. A medical history of any clinically significant medical disease or surgery within 4 weeks of the screening;
  6. Clinically significant laboratory abnormal results at screening or prior to the first dose of study drug;
  7. Clinically significant abnormal 12-lead ECG or vital signs ( systolic pressure <90 mmHg or >140 mmHg, diastolic pressure <50 mmHg or >90 mmHg; radial pulse rate <50 bpm or >100 bpm);
  8. Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening;
  9. Recent history of frequent alcohol consumption, defined by average intake of greater than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL of spirits with 40% alcohol content, or 150 mL wine), Participants who are unable to abstain from smoking during the study or quitting smoking for less than 3 months;
  10. Positive urine screen for drug and cigarettes, positive breath test for alcohol;
  11. Subjects who use soft drugs (ie marijuana )within 3 months of the screening and entire study duration or hard drugs (ie cocaine, phencyclidine ) within 1 year of the screening and entire study duration;
  12. Dietary habits or food intolerances which will interfere with the requirements for participants to consume a standardised diet whilst confined to the clinical unit;
  13. Participants who eat special food (Including grapefruit and/or Xanthine diet) for 14 days prior to dosing or any caffeine containing food or drinks, i.e. chocolate for 48 hours prior to dosing or drinking alcohol for 24 hours prior to dosing and not will stop to intake above food and drinks;
  14. Use of any drug that inhibits or induces hepatic metabolism of drugs within 30 days of planned study drug administration and entire study duration (e.g. inducers: barbiturates, carbamazepine, rifampicin, phenytoin, glucocorticoid and omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones and antihistamines);
  15. Participant who received any medicine within 14 days of the initial dose of study drug;
  16. Have received other clinical trials treatment within 3 months prior to study;
  17. Participants who have donated of blood (>400 mL) within 4 weeks of the study, or plan to donate of blood during of the study and 4 weeks after the study;
  18. Subjects cannot complete the study due to other reasons or by the investigator's judgment;
  19. Pregnancy or lactating females

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03577626


Contacts
Layout table for location contacts
Contact: Hongyun Wang, Doctor 86-10-69156576 wanghy@pumch.cn

Sponsors and Collaborators
Tianjin Hemay Bio-Tech Co., Ltd
Investigators
Layout table for investigator information
Principal Investigator: Hongyun Wang, Doctor Peking Union Medical College Hospital

Layout table for additonal information
Responsible Party: Tianjin Hemay Bio-Tech Co., Ltd
ClinicalTrials.gov Identifier: NCT03577626    
Other Study ID Numbers: HM005PS1S02
First Posted: July 5, 2018    Key Record Dates
Last Update Posted: July 5, 2018
Last Verified: June 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Hemay005
Dermatologic Agents
Phosphodiesterase 4 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action