Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000034437
Ethics application status
Approved
Date submitted
16/09/2015
Date registered
18/01/2016
Date last updated
10/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase I Study of Nifekalant in Healthy Chinese Male Volunteers.
Scientific title
A Phase I Single-Center Study to Determine the Pharmacokinetics and Pharmacodynamics of Nifekalant in Healthy Chinese Male Volunteers.
Secondary ID [1] 287461 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arrhythmias 296184 0
ventricular tachycardia 296737 0
Condition category
Condition code
Cardiovascular 296463 296463 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Volunteers were assigned to 3 treatment groups of Nifekalant: A/B/C,
For every volunteer, the clinical procedure could be divied into three periods.
Period 1, Day 1, volunteers received Nifekalant D1 mg/Kg through intravenous administration in 5 minutes..
Period 2, Day 2 and Day 3, no interventions
Period 3, Day 4, volunteers received Nifekalant D1 mg/Kg through intravenous administration in 5 minutes, then immediately followed by Nifekalant D2 mg/Kg/h through intravenous infusion by a infusion pump working for 6 hours.
For simplicity, we described the whole dose plan as (D1+ D1 mg/Kg + D2 mg/Kg/h) .
Group A : 8 volunteers received (0.3+0.3mg/Kg+0.4mg/Kg/h), 4 volunteers received (0.3+0.3mg/Kg/+0.8 mg/Kg/h)
Group B : 8 volunteers received (0.4+0.4mg/Kg+0.6mg/Kg/h), 4 volunteers received (0.4+0.4mg/Kg+0.8 mg/Kg/h)
Group C : 8 volunteers received (0.5+0.5mg/Kg+0.8mg/Kg/h), 4 volunteers received (0.5+0.5mg/Kg+0.6 mg/Kg/h)
Intervention code [1] 292836 0
Treatment: Drugs
Comparator / control treatment
No control treatment.
group A would be the comparator group.
Control group
Dose comparison

Outcomes
Primary outcome [1] 296093 0
composite primary outcome : pharmacokinetics/pharmacodynamic modeling. Pharmacokinetic model is simulated by nifekalant concentrations in plasma. QT interval is recorded by electrocardiogram monitoring and used as the pharmacodynamic index
Timepoint [1] 296093 0
For D1 dose on day 1, venous blood sample(5ml) will be taken and QT interval will be recorded at baseline, the end of infusion, 3, 5, 10, 15, 30, 60, 120, 240, 360, 480, 600 and 720 min after infusion.
For dose plan (D1 mg/Kg+D2mg/Kg/h) on day 4, venous blood sample(5ml) will be taken and QT interval will be recorded prior to and at the end of D1 dose (D1 dose will be finish in 5minutes and immediatly followed by D2 dose, D2 dose will be holding for 6 hours ), at 5, 15, 30, 60, 120, 240 and 360 min after the start of D2 dose, and at 3, 5, 10, 15, 30, 60, 120, 240, 360, 480, 600 and 720 min after the whole D2 dose period.
Secondary outcome [1] 317467 0
Safety evaluation: safety was evaluated by
1, General physical examination, subjective symptom, weight;
2, monitoring of vital signs, including blood pressure, body temperature, pulse, breathing;
3, Laboratory examination, including routine blood tests, routine urine tests and blood biochemical blood biochemical;
4. Adverse events, based on spontaneous reports by volunteers, questioning by investigators, physical examinations; The AE information was recorded throughout the study in terms of intensity (mild, moderate, or severe), duration, outcome, and relationship to the study drug.
5,ECG results,
Timepoint [1] 317467 0
ECG will be measured at baseline, and at 2h, 4h and 24h after infusion for single dose period. As for dose plan (D1+D2 mg/Kg),ECG will be measured prior to D1 dose, 2h, 4h, 6h after the start of D1 dose, and at 2h, 4h and 24h after D2 dose period.
Blood pressure will be measured at baseline, and at 15, 30, 60, 120, 240 and 1440 min after D1 dose on day 1 (D1 dose will be finished in 5 minutes).
On day 4 ( D1 mg/Kg+D2 mg/Kg/h),blood pressure will be measured prior to D1 dose (D1 dose will be finish in 5minutes and immediatly followed by D2 dose ), at 15, 30, 60, 120, 240 and 360 min after the start of D2 dose (D2 dose will be holding for 6 hours), and at 15, 30, 60, 120, 240 and 1080 min after the whole D2 dose period.
Laboratory examination and physical examination will be measured before administration and 24h after administration.

Eligibility
Key inclusion criteria
Healthy male Chinese volunteers between the ages of 19-40. Body mass index between 19 and 24 kg/m^2, nonsmokers, thorax radiography and electrocardiography without abnormalities, normal values of BP and heart rate and laboratory test results(hematology, blood biochemistry, hepatic function, and urinalysis), negative results on HIV and hepatitis types B and C testing.
Minimum age
19 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1, vital signs abnormal(SBP < 90mmHg or > 140mmHg, DBP < 50mmHg or > 90mmHg, HR < 50 bpm or > bpm).
2, Electrocardiographic abnormality with clinical significance or QTc interval > 400ms.
3, Holter monitor found sinus beat stop, third degree sinoatrial conduction block, atrioventricular block or heterotopic heart rate.
4, clinical significant allergies to drug or foods;
5, alcohol or drug abuse;
6, alcoholics or frequent drinkers 6 months before the study (that is 14 unit of alcohol weekly).
7, heavy smoker or smoking amount more than 5 cigarettes 3 months before the study
8, positive results on HIV and hepatitis types B and C testing
9, donate blood or participated in other clinical trials within 3 months before enrollment in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
1/03/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 7163 0
China
State/province [1] 7163 0
Beijing

Funding & Sponsors
Funding source category [1] 292035 0
Hospital
Name [1] 292035 0
Fuwai hospital
Country [1] 292035 0
China
Primary sponsor type
Hospital
Name
Fuwai hospital
Address
beilishi road 167#, xicheng district, Beijing, 100037
Country
China
Secondary sponsor category [1] 291047 0
None
Name [1] 291047 0
Address [1] 291047 0
Country [1] 291047 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293521 0
the ethics and research committees in Fuwai hospital
Ethics committee address [1] 293521 0
beilishi road 167#, xicheng district, Beijing, 100037
Ethics committee country [1] 293521 0
China
Date submitted for ethics approval [1] 293521 0
10/08/2015
Approval date [1] 293521 0
23/09/2015
Ethics approval number [1] 293521 0

Summary
Brief summary
The purpose of this study is to explore the pharmacokinetic and pharmacodynamics property of Nifekalant in Chinese healthy volunteers and provide important information for clinical application.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60278 0
Prof Yishi Li
Address 60278 0
Fuwai hospital, beilishi road 167#, xicheng district, Beijing, 100037
Country 60278 0
China
Phone 60278 0
+86 10-88398547
Fax 60278 0
Email 60278 0
[email protected]
Contact person for public queries
Name 60279 0
Prof Lei Tian
Address 60279 0
Fuwai hospital, beilishi road 167#, xicheng district, Beijing, 100037
Country 60279 0
China
Phone 60279 0
+86 10-88398547
Fax 60279 0
Email 60279 0
[email protected]
Contact person for scientific queries
Name 60280 0
Prof Lei Tian
Address 60280 0
Fuwai hospital, beilishi road 167#, xicheng district, Beijing, 100037
Country 60280 0
China
Phone 60280 0
+86 10-88398547
Fax 60280 0
Email 60280 0
[email protected]

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No Supporting Document Provided



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