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AnesthesiaPhase 1NCT04294056

A Study to Evaluate the Differences in Pharmadynamics, Pharmacokinetics, and Safety Between Ciprofol and Propofol

A Phase 1 study testing Ciprofol and Propofol in people with Anesthesia, run by Haisco Pharmaceutical Group 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 is a single-center, open-label, randomized, two-stage, two-way crossover Phase I study in healthy male subjects.The main objective is to evaluate the differences in pharmadynamics (PD), pharmacokinetics (PK), and safety between ciprofol injectable emulsion and propofol injectable emulsion at different doses in… Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Anesthesia
What is being tested?
Ciprofol and Propofol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
26 May 2020to 18 Sep 2020
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
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adult males, aged 18-45 years (inclusive);
  • Body weight ≥ 50 kg, body mass index (BMI) between 18-26 kg/m^2 (inclusive);
  • Blood pressure between 90-140/50-90 mmHg (inclusive); heart rate between 60-100 bpm (inclusive); body temperature between 35.4-37.5°C (inclusive); respiratory rate between 12-20 breaths per min (inclusive); SpO2 when inhaling ≥ 92%;
  • Normal results of physical examination, laboratory tests (routine blood, routine urine, blood biochemistry (including hepatic function, renal function, blood glucose, and electrolytes such as Na, K, and Mg), and blood coagulation), 12-lead ECG, and abdominal ultrasonography, or abnormalities considered by the investigators to be clinically insignificant; no significant potential difficult airway (modified Mallampati score Class I-II);
  • No previous history of primary diseases in major organs, such as liver, kidneys, digestive tract, blood, and metabolic diseases; no history of malignant hyperthermia and other hereditary disorders; no history of mental/neurological disorders; no history of epilepsy; no contraindications for deep sedation/general anesthesia; no clinically significant history of anesthesia accidents;
  • Subjects must understand the procedures and methods of this study, and be willing to signing the informed consent form and to complete the trial in strict accordance with clinical trial protocol;

Who cannot join

  • Patients with known allergies to ciprofol injectable emulsion, excipient in propofol injectable emulsion (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate, and sodium hydroxide); history of drug allergies (including other anesthetics), allergic diseases, or hyperactive immune response;
  • Patients receiving any of the following drugs or therapies prior to screening/administration:
  • History of drug abuse within 3 months prior to screening, or positive result in urine drug screening during baseline period;
  • Participated in other drug/medical device trials within 3 month prior to screening;
  • Serious infection, trauma, or major surgery within 4 weeks prior to screening.
  • Acute disease with clinical significance (determined by the investigators) within 2 weeks prior to screening, including GI diseases or infections (such as respiratory tract or CNS infections);
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  • Patients who received propofol, other sedatives/anesthetics, and/or opioid analgesics within 1 week prior to administration;
  • Patients who received prescription drugs, Chinese herbal medicines, over-the-counter drugs, or food supplements (such as vitamins and calcium supplements) other than contraceptives, paracetamol, oral non-steroidal anti-inflammatory drugs, and topical over-the-counter preparations, within 2 weeks prior to administration; those who received UGT or CYP2B6 inhibitors within 7 days prior to administration (refer to Attachment 6 for prohibited drugs); patients can only be enrolled when the principal investigator (PI) and the sponsor agree that the medication has no effect on the safety and PK/PD results of the trial;
  • Patients with history or evidence of any of the following diseases prior to screening/administration:
  • History of cardiovascular diseases, such as postural hypotension, severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction within 6 months before screening, tachycardia/bradycardia requiring medications, third-degree atrioventricular block, or QTcF interval ≥ 450 ms (per Fridericia's correction formula);
  • Subjects with hypopnea, history of obstructive pulmonary disease, history of asthma, or sleep apnea syndrome; subjects with history of failed endotracheal intubation; history of bronchospasm requiring interventions within 3 months prior to screening; acute upper respiratory tract infection within 1 week prior to baseline, with symptoms such as fever, wheeze, nasal obstruction, or cough;
  • History of gastrointestinal disorders: history of gastrointestinal retention, active hemorrhage, or conditions that may lead to reflux and aspiration;
  • Laboratory results meeting any of the following during screening/at baseline:
  • Positive result for any of the markers, including HBsAg, HCV-Ab, HIV-Ab, and Tp-Ab;
  • Results for hepatic and renal functions exceeding the following ranges:
  • ALT or AST > 50% of ULN; Creatinine > 20% of ULN; Total bilirubin > 40% of ULN.
  • History of alcohol abuse within 3 months prior to screening; alcohol abuse defined as average of > 2 units of alcohol per day (1 unit = 360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine), or positive alcohol breath test results at baseline;
  • Patients who smoked more than 5 cigarettes per day and a total of more than 60 cigarettes within 3 months prior to screening;
  • Blood donation or blood loss ≥ 200 mL within 30 days prior to screening; plasma donation or plasma exchange within 7 days prior to screening;
  • Subjects who consumed any beverages or foods containing alcohol, grapefruit juice or methylxanthine (such as coffee, tea, cola, chocolate, and energy drinks), participated in strenuous physical activities and had other factors that may affect drug absorption, distribution, metabolism, and excretion, within 2 days prior to baseline; subjects who were unable to fast for 8 hours before dose administration;
  • Subjects who were expected to go through surgery or hospitalization during the trial;
  • Subjects unsuitable for arterial blood collection, such as subjects with positive results in Allen's test;
  • Subjects who were unwilling to practice contraception during the trial; subjects who were planning to conceive within 3 month after the completion of the trial;
  • Subjects judged by the investigators to be unsuitable for participating in this trial for any reason.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sichuan Provincial People's Hospital

    Chengdu

Other trials in China

About this study

Official title: A Single-center, Open-label, Randomized, Two-stage, Two-way Crossover Study to Evaluate the Differences in Pharmadynamics, Pharmacokinetics, and Safety Between Ciprofol and Propofol at Different Doses in Healthy Subjects

This is a single-center, open-label, randomized, two-stage, two-way crossover Phase I study in healthy male subjects.The main objective is to evaluate the differences in pharmadynamics (PD), pharmacokinetics (PK), and safety between ciprofol injectable emulsion and propofol injectable emulsion at different doses in healthy subjects.

Conditions
Anesthesia
Being tested
Ciprofol, Propofol

What participants receive

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

  • CiprofolDrug

    First-stage: 0.4mg/kg, 0.6 mg/kg, 0.8 mg/kg Second-stage: 0.4mg/kg, 0.6 mg/kg, 0.8 mg/kg

  • PropofolDrug

    First-stage: 2.0mg/kg, 3.0 mg/kg, 4.0 mg/kg Second-stage: 2.0mg/kg, 3.0 mg/kg, 4.0 mg/kg

Study groups in NCT04294056
Study groupRoleWhat they receive
CiprofolExperimentalFirst-stage: 0.4mg/kg, 0.6 mg/kg, 0.8 mg/kg Second-stage: 0.4mg/kg, 0.6 mg/kg, 0.8 mg/kg
Receives: Drug: Ciprofol
PropofolActive comparatorFirst-stage: 2.0mg/kg, 3.0 mg/kg, 4.0 mg/kg Second-stage: 2.0mg/kg, 3.0 mg/kg, 4.0 mg/kg
Receives: Drug: Propofol

What is being measured

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

  1. Modified observer's assessment of alertness/sedation（MOAA/S）

    Observe the change of modified observer's assessment of alert /sedation during the whole trial

    Measured: From first dose of study drug until fully alert on day 1

  2. Bispectral index （BIS）

    Measured: From first dose of study drug until fully alert on day 1

  3. Safety by measurement of Adverse Events

    Measured: First dose of study drug on day 1

Secondary outcomes (7)

  1. Peak concentration (Cmax)

    Measured: First dose of study drug on day 1

  2. Area under the plasma concentration versus time curve (AUC)

    Measured: First dose of study drug on day 1

  3. Terminal half-life (t1/2)

    Measured: First dose of study drug on day 1

  4. time to peak concentration (Tmax)

    Measured: First dose of study drug on day 1

  5. clearance (CL)

    Measured: First dose of study drug on day 1

  6. mean residence time (MRT)

    Measured: First dose of study drug on day 1

  7. volume of distribution (Vz)

    Measured: First dose of study drug on day 1

Timeline

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

  1. First posted3 Mar 2020
  2. Study start26 May 2020
  3. Primary completion22 Jun 2020
  4. Study completion18 Sep 2020

Resources

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
Crossover
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04294056
Sponsor's protocol ID
HSK3486-109
Status last verified
Feb 2020
First submitted
28 Feb 2020
Last updated
20 Nov 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ciprofol and Propofol in people with Anesthesia, run by Haisco Pharmaceutical Group 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 6 inclusion and 24 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 Nov 2020. 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?

Modified observer's assessment of alertness/sedation（MOAA/S） (time frame: From first dose of study drug until fully alert on day 1). The study lists 3 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 NCT04294056.

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 Nov 2020.

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