Status:
COMPLETED
A Study Evaluating Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 and Etomidate for Induction of Anesthesia in Healthy Male Subjects
Lead Sponsor:
Sichuan Haisco Pharmaceutical Group Co., Ltd
Conditions:
General Anesthetic
Sedation
Eligibility:
MALE
18-49 years
Phase:
PHASE1
Brief Summary
This study is designed as an open label, single dose combination of HSK3486 and etomidate in healthy adult male subjects. The study will evaluate the anesthetic/sedation effect of the combination of t...
Eligibility Criteria
Inclusion
- Male, aged 18 - 49 years (inclusive)
- Be in general good health without clinically significant medical history, as determined by the investigator
- American Society of Anesthesiologists Physical Status Classification of I or II
- Body mass index (BMI) between 18 and 30 kg/m2 (inclusive)
- Negative screen for drugs of abuse, alcohol, hepatitis B surface antigen, hepatitis C and Human Immunodeficiency Virus (HIV) at screening; and drugs of abuse, alcohol pre dose on Day -1
- Normal or non-clinically significant findings on a physical examination, 12-lead ECG and vital signs (respiration rate between 12 and 20 breaths per minute, BP between 100-140/50-90 mmHg, heart rate between 45-99 beats per minute, temperature between 35.8 degrees and 37.5 degrees). Pulse oximetry values \>95% on room air.
- Clinical laboratory values within the normal limits as defined by the clinical laboratory, unless the investigator decides that out-of-range values are not clinically significant
- Ability to provide written informed consent
- Willing and able to follow study instructions and likely to complete all study requirements
- Suitable venous and arterial access.
Exclusion
- History of allergy or sensitivity to: propofol, etomidate or components of HSK3486 (excipients soy bean oil, glycerine, triglycerides, purified egg phospholipids, sodium oleate and sodium hydroxide), or plain lignocaine
- History of clinically significant problems with anesthesia induction
- Current smoker, or a history of regular (more than weekly) use of tobacco- or nicotine-containing products within 2 months prior to screening
- History of excessive alcohol intake (more than 4 standard drinks daily, on average) or use of recreational drugs within the last 3 months prior to screening
- Intake of \> 8 caffeine-containing drinks per day, on average, or approximately 800mg of caffenine daily on average; history of intolerance of abstinencce from caffeine for 3 days
- Use of prescription or over the counter medications within 7 days of investigational product administration, with the exception of paracetamol, oral non-steroidal anti-inflammatory agents, topical over the counter preparations and routine vitamins (if they do not exceed the recommended daily dose), unless agreed as non-clinically relevant by the investigator and sponsor.
- Standard donation of blood within 30 days of the study
- Donation of plasma or participation in a plasmapheresis program within 7 days of investigational product administration
- Receipt of any investigational study drug within 30 days prior to screening
- Unable to fast for the 6 hours prior to investigational product administration
- Clinically significant (as judged by the investigator) presence of acute illness (e.g. gastrointestinal illness, infection such as influenza, upper respiratory tract infection) at admission to the clinical study unit
- Anticipated need for surgery or hospitalization during the study
- Craniofacial abnormality that would potentially interfere with airway management under unconscious sedation or anesthesia
- History of seizures or epilepsy
- History of ischaemic heart disease
- History of brady- or tachy-dysrhythmias requiring medical care
- History of asthma, with bronchospasm requiring treatment in the last 3 months
- Any condition, which in the investigator's opinion, puts the subject at significant risk, could confound the study results or may interfere significantly with the subject's participation in the study
- Receipt of HSK3486 less than 4 weeks prior to the start of the study.
Key Trial Info
Start Date :
November 30 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2017
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04054063
Start Date
November 30 2016
End Date
June 28 2017
Last Update
August 13 2019
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