HealthyPhase 1NCT03458650
A Phase I Study of LuoXin Innovate (LXI-15028) in Healthy Chinese Subjects to Evaluate the Pharmacokinetics, Safety and Tolerability.
A Phase 1 study testing LXI-15028 50mg, LXI-15028 100mg and LXI-15028 200mg in people with Healthy, run by Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. at 1 site in China.
Trial summary
"This study is a single-center, randomized, double-blinded and placebo-controlled trial designed not only to assess pharmacokinetics, safety and tolerability of LXI-15028 but also to evaluate the pharmacokinetic characteristics of main metabolite M1 in vivo in 38 healthy adult Chinese subjects after receiving… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LXI-15028 50mg, LXI-15028 100mg and LXI-15028 200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2018to 8 May 2018
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subjects should voluntarily participate in this trial and sign the informed consent form prior to conducting any trial-related procedures;
- Gender: male or female healthy subjects; Age: 18~45 years old (including 18 and 45 years old);
- The body weight should be equal or greater than 50.0 kg for male and 45.0 kg for female. Body weight index (BMI)= body weight (kg)/[height(m)×height(m)], should be within the range from 19 to 25 (including 19 and 25);
- In the past three years, no history or presence of cardiovascular, hepatic, renal, respiratory, hematological and lymphatic, endocrine, immunological, mental, neurological and gastrointestinal disease; no history of surgery;
- The subjects (including males and females) agree to use medically approved contraceptive methods during the trial period and within 3 months after the end of the trial in order to avoid pregnancy; medically approved contraceptive methods include intrauterine device, physical barrier (male condom, female condom), subcutaneous implant, sustained-release contraceptive, bilateral salpingectomy, bilateral tubal ligation, bilateral vas ligation, etc.;
- The subjects agree not to donate sperms (males) or ova (females) at least 7 days before the first dose, during the study and within 3 months after ending of this study.
Who cannot join
- The subjects with allergic constitution, for example those with bronchial asthma, allergic to food or pollen, allergic to two or more drugs or those with known history of allergy ; or the subjects with any serious adverse response to Proton Pump Inhibitor or P-CABs previously (e.g., omeprazole, rabeprazole, lansoprazole and TAK-481 ), or known allergy to penicillins or cephalosporins;
- The investigator determines that it may potentially affect absorption, distribution, metabolism or elimination of investigational drug (e.g. organ dysfunction);
- The subjects with a history of drug abuse or drug abuse screening positive;
- The subjects received any drugs (including prescription drugs, Over-The-Counter drugs, herbal medicines, etc.) within 1 month before the screening or are taking drugs, especially CYP3A inhibitor or inducer (see Appendix 1);
- The subjects with clinical significant physical examination abnormalities determined by investigator;
- Heart rate<50 beats/min or >100 beats/min or QTc interval prolonged (male QTcF≥430ms, female QTcF≥450ms) or QRS≥120 msec or other clinically significant ECG abnormalities; 7) The subjects with sitting blood pressure: systolic pressure <90mmHg or ≥ 140mmHg, diastolic pressure ≥90mmHg or <60mmHg, which shows clinical significant abnormalities determined by investigators
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- The subjects with any biomarker value of Aspartate aminotransferase (AST),Alanine aminotransferase(ALT), Alkaline phosphatase(ALP),r-Glutamyl Transferase (r-GT), total bilirubin, creatinine above the upper limit of normal or with other clinical significant laboratory examination abnormalities judged by investigators
- The subjects with presence of one of the following infectious diseases;
- Virological determination indicates hepatitis B virus surface antigen (HBsAg) positive or anti-hepatitis C virus antibody positive;
- Acquired human immunodeficiency virus determination indicates infection; (anti-human immunodeficiency virus antibody positive)
- Treponema pallidum infection (anti-treponema pallidum-specific antibody positive).
- Currently smoking or quitting smoking less than 3 months before screening or tobacco screening positive;
- Chronical alcohol user within 5 years prior to screening, or alcohol consumption of more than 14 unit alcohol per week (1 unit alcohol equal to 360 mL beer, or 150 mL grape wine, or 45 mL wine of 40 degree) within 6 months prior to screening;
- Alcohol screening test positive or alcohol intake within 72 h prior to screening;
- Daily drinking a large amount (above 1000 mL) of tea, coffee, cola and/or caffeine-containing beverages within 6 months prior to screening;
- Taking xanthine-containing or caffeine-containing food or beverages (including chocolate, tea, coffee and cola, etc.) from 48 hours prior to screening;
- Taking grapefruit, lime, carambola or any food or beverages made from them within 7 days prior to screening;
- Female subjects with blood pregnancy test positive or during lactation
- Difficulty in blood sampling, or has relevant history, symptoms or signs of blood sampling difficulty;
- Transfusion treatment or blood donation or massive blood loss (exceeding 450 mL) judged by investigators within 3 months prior to screening;
- Participation in any other clinical study within 3 months prior to screening;
- Participation in the planning or execution of this study (e.g., the sponsor or staff in the site);
- Inappropriate to participate in this study for any reason according to the medical judgment of investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
Official title: A Single-center, Randomized, Double-blinded and Placebo-controlled Clinical Study in Healthy Chinese Subjects to Evaluate the Pharmacokinetics, Safety and Tolerability of LXI-15028 After Receiving Escalating Single Oral Doses of LXI-15028 at 50 mg, 100 mg and 200 mg and Multiple Oral Doses of LXI-15028 at 100 mg
"This study is a single-center, randomized, double-blinded and placebo-controlled trial designed not only to assess pharmacokinetics, safety and tolerability of LXI-15028 but also to evaluate the pharmacokinetic characteristics of main metabolite M1 in vivo in 38 healthy adult Chinese subjects after receiving escalating single oral doses of 50 mg, 100 mg and 200 mg and multiple oral doses of 100 mg of LXI-15028.
Read the detailed description
This study includes 3 dose groups which are 50 mg (Group 1), 100 mg(Group 2) and 200 mg(Group 3) respectively. For 50 mg and 200 mg dose groups, each is planned to enroll 12 healthy subjects (investigational drug :placebo=10:2), half males and half females. Five subjects of each gender will receive LXI-15028, while 1 subject of each gender will receive placebo; 100 mg dose group plans to enroll 14 healthy subjects (investigational drug:placebo=10:4), half males and half females. Five subjects of each gender will receive LXI-15028, while 2 subjects of each gender will receive placebo. Intra-group randomization will be implemented in each dose group; each subject will receive either LXI-15028 or placebo.
This study includes 2 parts of single-dose and multiple-dose administration. The single-dose study will use gradually escalation dosing to evaluate the 3 doses of 50 mg, 100 mg and 200 mg. Within 4 days after each dose is administered, the investigators will assess the safety and tolerability data to decide whether to proceed with the next escalated single dose. Within 4 days of 200 mg single-dose administration, the investigators will assess the safety and tolerability data to decide whether to proceed with 100 mg multiple-dose study. Multiple-dose study will be investigated in 100 mg group only.
The study consists of screening period, treatment period and follow-up in each dose group. The treatment period in 50 mg and 200 mg dose groups include single-dose administration only. While the treatment period in 100 mg dose group includes both single-dose and multiple-dose administration. The subjects in 100 mg dose group will enter multiple-dose period following completing single-dose period.
In escalated single-dose study, the subjects in each dose group will receive single oral dose of 50 mg LXI-15028 tablet or 1 matching placebo tablet at fasted state, or 100 mg LXI-15028 tablet or matching placebo 1 tablet, or 2 100 mg LXI-15028 tablets or 2 matching placebo tablets. Blood samples will be collected before administration (0h), and 15 min (0.25h), 30 min (0.5h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h and 72h after administration. In multiple-dose study, the subjects will continuously receive oral 100 mg LXI-15028 tablet or 1 matching placebo tablet once daily (QD) for 10 times. Blood samples of trough concentration will be collected before the 8th to 10th administration (0h) in multiple-dose study. And blood samples will be collected at 15 min (0.25h), 30 min (0.5h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h and 72h after the 10th administration.
The collected blood samples will be processed to obtain plasma. Liquid Chromatographic(LC) /Mass Spectra(MS)/Mass Spectra (MS) method will be used to determine plasma concentrations of LXI-15028 and its major metabolite M1 in order to evaluate the pharmacokinetic characteristics of LXI-15028 and its metabolite M1 after oral administration of LXI-15028 tablet.
The safety will be assessed by physical examination, vital signs, ECG, laboratory examinations and adverse events in subjects receiving LXI-15028 tablet.
"
- Conditions
- Healthy
- Being tested
- LXI-15028 50mg, LXI-15028 100mg, LXI-15028 200mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LXI-15028 50mgDrug
In escalated single-dose study, the subjects in each dose group will receive single oral dose of 50 mg LXI-15028 tablet or 1 matching placebo tablet at fasted state,
LXI-15028 100mgDrug
100 mg LXI-15028 tablet or matching placebo 1 tablet at fasted state, In multiple-dose study, the subjects who administered 100mg single dose will continuously receive oral 100 mg LXI-15028 tablet or 1 matching placebo tablet once daily (QD) for 10 times.
LXI-15028 200mgDrug
single oral dose 2 100 mg LXI-15028 tablets or 2 matching placebo tablets at fasted state
PlaceboDrug
matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| LXI-15028 50 mg | Experimental | For 50 mg dose groups, each is planned to enroll 12 healthy subjects (investigational drug :placebo=10:2), half males and half females. Five subjects of each gender will receive LXI-15028, while 1 subject of each gender will receive placebo Receives: Drug: LXI-15028 50mg; Drug: Placebo |
| LXI-15028 100 mg | Experimental | 100 mg dose group plans to enroll 14 healthy subjects (investigational drug:placebo=10:4), half males and half females. Five subjects of each gender will receive LXI-15028, while 2 subjects of each gender will receive placebo. Intra-group randomization will be implemented in each dose group; each subject will receive either LXI-15028 or placebo. Receives: Drug: LXI-15028 100mg; Drug: Placebo |
| LXI-15028 200 mg | Experimental | 200 mg dose groups, each is planned to enroll 12 healthy subjects (investigational drug :placebo=10:2), half males and half females. Five subjects of each gender will receive LXI-15028, while 1 subject of each gender will receive placebo Receives: Drug: LXI-15028 200mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter： Cmax
The maximum plasma concentration (Cmax) after single dose LXI-15028
Measured: 72 h after receiving single oral dose
Pharmacokinetic parameter： Tmax
The peak time (Tmax) after single dose LXI-15028
Measured: 72 h after receiving single oral dose
Pharmacokinetic parameter： T1/2
The elimination half-life T1/2 after single dose LXI-15028
Measured: 72 h after receiving single oral dose
Pharmacokinetic parameter： Kel
The eliminate rate constant after single dose LXI-15028
Measured: 72 h after receiving single oral dose
Pharmacokinetic parameter：Mean Residence Time(MRT)
The mean residence time after single dose LXI-15028
Measured: 72 h after receiving single oral dose
Pharmacokinetic parameter: Area Under plasma Concentration(AUC 0-24h)
The area under plasma concentration -time curve from 0 time ot 24 h after single dose LXI-15028
Measured: 24h after receiving single oral dose
Pharmacokinetic parameter: AUC 0-last
The area under plasma concentration- time curve from 0 time to sampling time of the last measurable concentration after single dose LXI-15028
Measured: 72h after receiving single oral dose
Pharmacokinetic parameter: AUC 0-inf
The area under plasma concentration-time curve from adminstration (0)to infinity after single dose LXI-15028
Measured: 72h after receiving single oral dose
Pharmacokinetic parameter: Vd/F
The apparent volume of distribution after single dose LXI-15028
Measured: 72h after receiving single oral dose
Pharmacokinetic parameter: Css min
The trough concentration at steady state(Css min) after multiple doses
Measured: predose at day 8, 9, and 10, 72 h after receiving last multiple oral doses
Pharmacokinetic parameter: Css max
The peak concentration at steady state (Css max) after multiple doses
Measured: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter: Css av
The average concentration at steady state (Css, av)after multiple doses
Measured: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter: Tss max
The peak time after multiple doses
Measured: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter: Tss,1/2
The steady-state clearance half-time after multiple doses
Measured: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter: CLss/F
Total body clearance after multiple doses
Measured: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter: coefficient of fluctuation (DF)
coefficient of fluctuation after multiple doses
Measured: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter: Area Under plasma Concentration at steady state (AUC ss)
The area under plasma concentration-time curve at steady state after multiple doses
Measured: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter: Rac
The accumulation coefficient after multiple doses
Measured: 72 h after receiving last multiple oral doses
Physical examination value of single dose
This measure is a composite. Evaluate safety and tolerability of single dose in Physical examination that should cover the head, eyes, ears, nose, throat, cardiovascular system, skin, musculoskeletal, respiratory system, digestive system, urinary system and nervous system and changes of each item from the baseline are summarized. The measurement results of each subject are summarized by different severity. All physical examination results during this trial will be listed in details.
Measured: Baseline to Day 4 after receiving single oral dose
Vital signs value of single dose
The measure is a composite.Evaluate safety and tolerability of single dose in Vital signs value that including blood pressure (Systolic blood pressure/Diastolic blood pressure), pulse, body temperature，each vital sign examination values at each evaluation time point and their changes relative to the baseline will be summarized. All vital sign results should be listed. The listed vital signs are compared with normal ranges to determine whether is abnormal. The examination results that are divided into higher than normal range, normal and lower than normal range will be summarized by number of cases (n) and percentage (%). The results of abnormalities(> or < normal range) are listed.
Measured: Up to 3weeks
12-lead ECG value of single dose
Evaluate safety and tolerability of single dose in 12-lead ECG value that including ventricular rate (beats/min), PR interval (ms), QRS (ms) , QT(ms),QTc (ms)， the examination results of each ECG parameters and their changes from baseline will be summarized at each time point. Meanwhile, all 12-lead ECG examination results will be listed in details.
Measured: Up to 3 weeks
Blood routine value of single dose
Evaluate safety and tolerability of single dose in blood routine value that including White blood cells (WBC), red blood cells (RBC), hemoglobin (Hb), hematocrit (Hct), platelet, neutrophils, lymphocytes, monocytes, eosinophils, basophils, absolute neutrophil counts (ANC);and list all the result.
Measured: Baseline to Day 4 after receiving single oral dose
Urine routine value of single dose
Evaluate safety and tolerability of single dose in urine routine value that including specific gravity, pH, proteins, ketone,occult blood; and list all the result.
Measured: Baseline to Day 4 after receiving single oral dose
Blood coagulation value of single dose
Evaluate safety and tolerability of single dose in blood coagulation value that including International normalized ratio (INR), activated partial thromboplastin time (aPTT), prothrombin time (PT); and list all the result.
Measured: Baseline to Day 4 after receiving single oral dose
Blood biochemistry value of single dose
Evaluate safety and tolerability of single dose in blood biochemistry value that including Cholesterol, total proteins, albumin, total bilirubin, Conjugated bilirubin, creatinine, creatine kinase (CPK), alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), glutamyltransferase (γ-GT), magnesium, sodium, potassium, chlorine, total calcium, inorganic phosphorus, lactate dehydrogenase (LDH), glucose, uric acid, triglyceride (TG); and list all the result.
Measured: Baseline to Day 4 after receiving single oral dose
Adverse events of single dose
The adverse events are encoded using MedDRA 20.1. According to system organ classification (SOC) and preferred term (PT), all TEAE, investigational drug-related TEAE, Serious Adverse Event, investigational drug-related SAE, and TEAE causing premature withdrawal from this study will be separately summarized by different dose groups, including number of subjects experiencing Adverse Event, percentage and number of AE cases. The summary results are sorted according to the ranking number of cases of all subjects experiencing AE. All AE and SAE are listed by different dose groups.
Measured: Up to 3 weeks
Physical examination value of multiple doses
The measure is a composite. Evaluate safety and tolerability of multiple doses in Physical examination that should cover the head, eyes, ears, nose, throat, cardiovascular system, skin, musculoskeletal, respiratory system, digestive system, urinary system and nervous system and changes of each item from the baseline are summarized. The measurement results of each subject are summarized by different severity. All physical examination results during this trial will be listed in details.
Measured: Baseline to Day 21 after receiving the first dose
Vital signs value of multiple doses
The measure is a composite.Evaluate safety and tolerability of multiple doses in Vital signs value that including blood pressure(Systolic blood pressure/Diastolic blood pressure), pulse, body temperature.Each vital sign examination values at each evaluation time point and their changes relative to the baseline will be summarized. All vital sign results should be listed. The listed vital signs are compared with normal ranges to determine whether is abnormal. The examination results that are divided into higher than normal range, normal and lower than normal range will be summarized by number of cases (n) and percentage (%). The results of abnormalities(> or < normal range) are listed.
Measured: Baseline to Day 21 after receiving the first dose
12-lead ECG value of multiple doses
Evaluate safety and tolerability of multiple doses in 12-lead ECG value that including ventricular rate (beats/min) ，PR interval (ms)， QRS (ms) ,，QT(ms)， QT interval (QTc )(ms). The examination results of each ECG parameters and their changes from baseline will be summarized at each time point. Meanwhile, all 12-lead ECG examination results will be listed in details.
Measured: :Baseline to Day 21 after receiving the first dose
Blood routine value of multiple doses
Evaluate safety and tolerability of multiple doses in blood routine value that including White blood cells (WBC), red blood cells (RBC), hemoglobin (Hb), hematocrit (Hct), platelet, neutrophils, lymphocytes, monocytes, eosinophils, basophils, absolute neutrophil counts (ANC); and list all the result.
Measured: Baseline to Day 21 after receiving the first dose
Urine routine value of multiple doses
Evaluate safety and tolerability of multiple doses in urine routine value that including specific gravity, potential of hydrogen (pH), proteins, ketone,occult blood; and list all the result.
Measured: Baseline to Day 21 after receiving the first dose
Blood coagulation value of multiple doses
Evaluate safety and tolerability of multiple doses in blood coagulation value that including International normalized ratio (INR), activated partial thromboplastin time (aPTT), prothrombin time (PT);
Measured: Baseline to Day 21 after receiving the first dose
Blood biochemistry value of multiple doses
Evaluate safety and tolerability of multiple doses in blood biochemistry value that including Cholesterol, total proteins, albumin, total bilirubin, Conjugated bilirubin, creatinine, creatine kinase (CPK), alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), glutamyltransferase (γ-GT), magnesium, sodium, potassium, chlorine, total calcium, inorganic phosphorus, lactate dehydrogenase (LDH), glucose, uric acid, triglyceride (TG); and list all the result.
Measured: Baseline to Day 21 after receiving the first dose
Adverse events of multiple doses
The adverse events are encoded using MedDRA 20.1. According to system organ classification (SOC) and preferred term (PT), all treatment-emergent adverse event (TEAE), investigational drug-related TEAE, serious adverse event (SAE), investigational drug-related SAE, and TEAE causing premature withdrawal from this study will be separately summarized by different dose groups, including number of subjects experiencing AE, percentage and number of adverse event (AE) cases. The summary results are sorted according to the ranking number of cases of all subjects experiencing AE. All AE and SAE are listed by different dose groups.
Measured: Up to 6 weeks
Secondary outcomes (20)
Pharmacokinetic parameter of major metabolite(M1): Cmax
Major metabolite (M1) of LXI-15028 Plasma PK parameters of single doses: peak concentration Cmax
Measured: 72 h after receiving single oral doses
Pharmacokinetic parameter of major metabolite(M1): Tmax
Major metabolite (M1) of LXI-15028 Plasma PK parameters of single doses: peak time Tmax
Measured: 72 h after receiving single oral doses
Pharmacokinetic parameter of major metabolite(M1): T1/2
Major metabolite (M1) of LXI-15028 Plasma PK parameters of single doses: elimination half-life T1/2
Measured: 72 h after receiving single oral doses
Pharmacokinetic parameter of major metabolite(M1): Kel
Major metabolite (M1) of LXI-15028 Plasma PK parameters of single doses: eliminate rate constant
Measured: 72 h after receiving single oral dose
Pharmacokinetic parameter of major metabolite(M1): MRT
Major metabolite (M1) of LXI-15028 Plasma PK parameters of single doses: mean residence time
Measured: 72 h after receiving single oral dose
Pharmacokinetic parameter of major metabolite(M1): AUC 0-24h
Major metabolite (M1) of LXI-15028 Plasma PK parameters of single doses: area under plasma concentration-time curve from 0 time to 24 hours
Measured: 24 h after receiving single oral dose
Pharmacokinetic parameter of major metabolite(M1): AUC 0-last
Major metabolite (M1) of LXI-15028 Plasma PK parameters of single doses: area under plasma concentration-time curve from 0 time to the last measurable concentration
Measured: 72 h after receiving single oral dose
Pharmacokinetic parameter of major metabolite(M1): AUC 0-inf
Major metabolite (M1) of LXI-15028 Plasma PK parameters of single doses: area under plasma concentration-time curve from 0 time to infinity
Measured: 72h after receiving single oral dose
Pharmacokinetic parameter of major metabolite(M1): CL/F
Major metabolite (M1) of LXI-15028 Plasma PK parameters of single dose:apparent total clearance
Measured: 72h after receiving single oral dose
Pharmacokinetic parameter of major metabolite(M1): Vd/F
Major metabolite (M1) of LXI-15028 Plasma PK parameters of single dose: apparent volume of distribution
Measured: 72h after receiving single oral dose
Pharmacokinetic parameter of major metabolite(M1): Css, min
Major metabolite (M1) of LXI-15028 Plasma PK parameters of multiple doses: trough concentration at steady state
Measured: :predose at day 8, 9, and 10, 72 h after receiving last multiple oral doses
Pharmacokinetic parameter of major metabolite(M1): Css, max
Major metabolite (M1) of LXI-15028 Plasma PK parameters of multiple doses:peak concentration at steady state
Measured: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter of major metabolite(M1): Css, av
Major metabolite (M1) of LXI-15028 Plasma PK parameters of multiple doses: average concentration at steady state
Measured: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter of major metabolite(M1): Tss, max
Major metabolite (M1) of LXI-15028 Plasma PK parameters of multiple doses: peak time
Measured: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter of major metabolite(M1): Vss/F
Major metabolite (M1) of LXI-15028 Plasma Pharmacokinetic parameters of multiple doses:apparent volume of distribution at steady state
Measured: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter of major metabolite(M1): tss,1/2
Major metabolite (M1) of LXI-15028 Plasma Pharmacokinetic parameters of multiple doses:steady-state clearance half-life
Measured: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter of major metabolite(M1): CLss/F
Major metabolite (M1) of LXI-15028 Plasma Pharmacokinetic parameters of multiple doses:total body clearance
Measured: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter of major metabolite(M1): DF
Major metabolite (M1) of LXI-15028 Plasma Pharmacokinetic parameters of multiple doses: coefficient of fluctuation
Measured: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter of major metabolite(M1): AUCss
Major metabolite (M1) of LXI-15028 Plasma Pharmacokinetic parameters of multiple doses: area under plasma concentration-time curve at steady state
Measured: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter of major metabolite(M1): Rac
Major metabolite (M1) of LXI-15028 Plasma PK parameters of multiple doses: accumulation coefficient
Measured: 72 h after receiving last multiple oral doses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start19 Mar 2018
- Primary completion23 Apr 2018
- Study completion8 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Zhang, Doctor, Principal investigator, Chief technician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458650
- Sponsor's protocol ID
- NE821605
- Status last verified
- Mar 2018
- First submitted
- 25 Jan 2018
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blinded and Placebo-controlled Clinical Study in Healthy Chinese Subjects to Evaluate the Pharmacokinetics, Safety and Tolerability of LXI-15028 After Receiving Escalating Single Oral Doses of LXI-15028 at 50 mg, 100 mg and 200 mg and Multiple Oral Doses of LXI-15028 at 100 mg
- ClinicalTrials.gov ID
- NCT03458650
- Acronym / sponsor ID
- NE821605
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 23 Apr 2018 (actual)
- Study completion
- 8 May 2018 (actual)
- First posted
- 8 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"This study is a single-center, randomized, double-blinded and placebo-controlled trial designed not only to assess pharmacokinetics, safety and tolerability of LXI-15028 but also to evaluate the pharmacokinetic characteristics of main metabolite M1 in vivo in 38 healthy adult Chinese subjects after receiving escalating single oral doses of 50 mg, 100 mg and 200 mg and multiple oral doses of 100 mg of LXI-15028.
Detailed description
This study includes 3 dose groups which are 50 mg (Group 1), 100 mg(Group 2) and 200 mg(Group 3) respectively. For 50 mg and 200 mg dose groups, each is planned to enroll 12 healthy subjects (investigational drug :placebo=10:2), half males and half females. Five subjects of each gender will receive LXI-15028, while 1 subject of each gender will receive placebo; 100 mg dose group plans to enroll 14 healthy subjects (investigational drug:placebo=10:4), half males and half females. Five subjects of each gender will receive LXI-15028, while 2 subjects of each gender will receive placebo. Intra-group randomization will be implemented in each dose group; each subject will receive either LXI-15028 or placebo.
This study includes 2 parts of single-dose and multiple-dose administration. The single-dose study will use gradually escalation dosing to evaluate the 3 doses of 50 mg, 100 mg and 200 mg. Within 4 days after each dose is administered, the investigators will assess the safety and tolerability data to decide whether to proceed with the next escalated single dose. Within 4 days of 200 mg single-dose administration, the investigators will assess the safety and tolerability data to decide whether to proceed with 100 mg multiple-dose study. Multiple-dose study will be investigated in 100 mg group only.
The study consists of screening period, treatment period and follow-up in each dose group. The treatment period in 50 mg and 200 mg dose groups include single-dose administration only. While the treatment period in 100 mg dose group includes both single-dose and multiple-dose administration. The subjects in 100 mg dose group will enter multiple-dose period following completing single-dose period.
In escalated single-dose study, the subjects in each dose group will receive single oral dose of 50 mg LXI-15028 tablet or 1 matching placebo tablet at fasted state, or 100 mg LXI-15028 tablet or matching placebo 1 tablet, or 2 100 mg LXI-15028 tablets or 2 matching placebo tablets. Blood samples will be collected before administration (0h), and 15 min (0.25h), 30 min (0.5h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h and 72h after administration. In multiple-dose study, the subjects will continuously receive oral 100 mg LXI-15028 tablet or 1 matching placebo tablet once daily (QD) for 10 times. Blood samples of trough concentration will be collected before the 8th to 10th administration (0h) in multiple-dose study. And blood samples will be collected at 15 min (0.25h), 30 min (0.5h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h and 72h after the 10th administration.
The collected blood samples will be processed to obtain plasma. Liquid Chromatographic(LC) /Mass Spectra(MS)/Mass Spectra (MS) method will be used to determine plasma concentrations of LXI-15028 and its major metabolite M1 in order to evaluate the pharmacokinetic characteristics of LXI-15028 and its metabolite M1 after oral administration of LXI-15028 tablet.
The safety will be assessed by physical examination, vital signs, ECG, laboratory examinations and adverse events in subjects receiving LXI-15028 tablet.
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Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LXI-15028 50 mg | Experimental | Drug: LXI-15028 50mg, Drug: PlaceboFor 50 mg dose groups, each is planned to enroll 12 healthy subjects (investigational drug :placebo=10:2), half males and half females. Five subjects of each gender will receive LXI-15028, while 1 subject of each gender will receive placebo |
| LXI-15028 100 mg | Experimental | Drug: LXI-15028 100mg, Drug: Placebo100 mg dose group plans to enroll 14 healthy subjects (investigational drug:placebo=10:4), half males and half females. Five subjects of each gender will receive LXI-15028, while 2 subjects of each gender will receive placebo. Intra-group randomization will be implemented in each dose group; each subject will receive either LXI-15028 or placebo. |
| LXI-15028 200 mg | Experimental | Drug: LXI-15028 200mg, Drug: Placebo200 mg dose groups, each is planned to enroll 12 healthy subjects (investigational drug :placebo=10:2), half males and half females. Five subjects of each gender will receive LXI-15028, while 1 subject of each gender will receive placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The subjects should voluntarily participate in this trial and sign the informed consent form prior to conducting any trial-related procedures;
- Gender: male or female healthy subjects; Age: 18~45 years old (including 18 and 45 years old);
- The body weight should be equal or greater than 50.0 kg for male and 45.0 kg for female. Body weight index (BMI)= body weight (kg)/[height(m)×height(m)], should be within the range from 19 to 25 (including 19 and 25);
- In the past three years, no history or presence of cardiovascular, hepatic, renal, respiratory, hematological and lymphatic, endocrine, immunological, mental, neurological and gastrointestinal disease; no history of surgery;
- The subjects (including males and females) agree to use medically approved contraceptive methods during the trial period and within 3 months after the end of the trial in order to avoid pregnancy; medically approved contraceptive methods include intrauterine device, physical barrier (male condom, female condom), subcutaneous implant, sustained-release contraceptive, bilateral salpingectomy, bilateral tubal ligation, bilateral vas ligation, etc.;
Key exclusion criteria (23 listed)
- The subjects with allergic constitution, for example those with bronchial asthma, allergic to food or pollen, allergic to two or more drugs or those with known history of allergy ; or the subjects with any serious adverse response to Proton Pump Inhibitor or P-CABs previously (e.g., omeprazole, rabeprazole, lansoprazole and TAK-481 ), or known allergy to penicillins or cephalosporins;
- The investigator determines that it may potentially affect absorption, distribution, metabolism or elimination of investigational drug (e.g. organ dysfunction);
- The subjects with a history of drug abuse or drug abuse screening positive;
- The subjects received any drugs (including prescription drugs, Over-The-Counter drugs, herbal medicines, etc.) within 1 month before the screening or are taking drugs, especially CYP3A inhibitor or inducer (see Appendix 1);
- The subjects with clinical significant physical examination abnormalities determined by investigator;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LXI-15028 50mgIn escalated single-dose study, the subjects in each dose group will receive single oral dose of 50 mg LXI-15028 tablet or 1 matching placebo tablet at fasted state, | Drug | LXI-15028 50 mg |
| LXI-15028 100mg100 mg LXI-15028 tablet or matching placebo 1 tablet at fasted state, In multiple-dose study, the subjects who administered 100mg single dose will continuously receive oral 100 mg LXI-15028 tablet or 1 matching placebo tablet once daily (QD) for 10 times. | Drug | LXI-15028 100 mg |
| LXI-15028 200mgsingle oral dose 2 100 mg LXI-15028 tablets or 2 matching placebo tablets at fasted state | Drug | LXI-15028 200 mg |
| Placebomatching placebo tablets | Drug | LXI-15028 100 mg, LXI-15028 200 mg, LXI-15028 50 mg |
Primary outcome
Pharmacokinetic parameter： Cmax
Time frame: 72 h after receiving single oral dose
The maximum plasma concentration (Cmax) after single dose LXI-15028
Pharmacokinetic parameter： Tmax
Time frame: 72 h after receiving single oral dose
The peak time (Tmax) after single dose LXI-15028
Pharmacokinetic parameter： T1/2
Time frame: 72 h after receiving single oral dose
The elimination half-life T1/2 after single dose LXI-15028
Pharmacokinetic parameter： Kel
Time frame: 72 h after receiving single oral dose
The eliminate rate constant after single dose LXI-15028
Pharmacokinetic parameter：Mean Residence Time(MRT)
Time frame: 72 h after receiving single oral dose
The mean residence time after single dose LXI-15028
Pharmacokinetic parameter: Area Under plasma Concentration(AUC 0-24h)
Time frame: 24h after receiving single oral dose
The area under plasma concentration -time curve from 0 time ot 24 h after single dose LXI-15028
Pharmacokinetic parameter: AUC 0-last
Time frame: 72h after receiving single oral dose
The area under plasma concentration- time curve from 0 time to sampling time of the last measurable concentration after single dose LXI-15028
Pharmacokinetic parameter: AUC 0-inf
Time frame: 72h after receiving single oral dose
The area under plasma concentration-time curve from adminstration (0)to infinity after single dose LXI-15028
Pharmacokinetic parameter: Vd/F
Time frame: 72h after receiving single oral dose
The apparent volume of distribution after single dose LXI-15028
Pharmacokinetic parameter: Css min
Time frame: predose at day 8, 9, and 10, 72 h after receiving last multiple oral doses
The trough concentration at steady state(Css min) after multiple doses
Pharmacokinetic parameter: Css max
Time frame: 72 h after receiving last multiple oral doses
The peak concentration at steady state (Css max) after multiple doses
Pharmacokinetic parameter: Css av
Time frame: 72 h after receiving last multiple oral doses
The average concentration at steady state (Css, av)after multiple doses
Pharmacokinetic parameter: Tss max
Time frame: 72 h after receiving last multiple oral doses
The peak time after multiple doses
Pharmacokinetic parameter: Tss,1/2
Time frame: 72 h after receiving last multiple oral doses
The steady-state clearance half-time after multiple doses
Pharmacokinetic parameter: CLss/F
Time frame: 72 h after receiving last multiple oral doses
Total body clearance after multiple doses
Pharmacokinetic parameter: coefficient of fluctuation (DF)
Time frame: 72 h after receiving last multiple oral doses
coefficient of fluctuation after multiple doses
Pharmacokinetic parameter: Area Under plasma Concentration at steady state (AUC ss)
Time frame: 72 h after receiving last multiple oral doses
The area under plasma concentration-time curve at steady state after multiple doses
Pharmacokinetic parameter: Rac
Time frame: 72 h after receiving last multiple oral doses
The accumulation coefficient after multiple doses
Physical examination value of single dose
Time frame: Baseline to Day 4 after receiving single oral dose
This measure is a composite. Evaluate safety and tolerability of single dose in Physical examination that should cover the head, eyes, ears, nose, throat, cardiovascular system, skin, musculoskeletal, respiratory system, digestive system, urinary system and nervous system and changes of each item from the baseline are summarized. The measurement results of each subject are summarized by different severity. All physical examination results during this trial will be listed in details.
Vital signs value of single dose
Time frame: Up to 3weeks
The measure is a composite.Evaluate safety and tolerability of single dose in Vital signs value that including blood pressure (Systolic blood pressure/Diastolic blood pressure), pulse, body temperature，each vital sign examination values at each evaluation time point and their changes relative to the baseline will be summarized. All vital sign results should be listed. The listed vital signs are compared with normal ranges to determine whether is abnormal. The examination results that are divided into higher than normal range, normal and lower than normal range will be summarized by number of cases (n) and percentage (%). The results of abnormalities(> or < normal range) are listed.
12-lead ECG value of single dose
Time frame: Up to 3 weeks
Evaluate safety and tolerability of single dose in 12-lead ECG value that including ventricular rate (beats/min), PR interval (ms), QRS (ms) , QT(ms),QTc (ms)， the examination results of each ECG parameters and their changes from baseline will be summarized at each time point. Meanwhile, all 12-lead ECG examination results will be listed in details.
Blood routine value of single dose
Time frame: Baseline to Day 4 after receiving single oral dose
Evaluate safety and tolerability of single dose in blood routine value that including White blood cells (WBC), red blood cells (RBC), hemoglobin (Hb), hematocrit (Hct), platelet, neutrophils, lymphocytes, monocytes, eosinophils, basophils, absolute neutrophil counts (ANC);and list all the result.
Urine routine value of single dose
Time frame: Baseline to Day 4 after receiving single oral dose
Evaluate safety and tolerability of single dose in urine routine value that including specific gravity, pH, proteins, ketone,occult blood; and list all the result.
Blood coagulation value of single dose
Time frame: Baseline to Day 4 after receiving single oral dose
Evaluate safety and tolerability of single dose in blood coagulation value that including International normalized ratio (INR), activated partial thromboplastin time (aPTT), prothrombin time (PT); and list all the result.
Blood biochemistry value of single dose
Time frame: Baseline to Day 4 after receiving single oral dose
Evaluate safety and tolerability of single dose in blood biochemistry value that including Cholesterol, total proteins, albumin, total bilirubin, Conjugated bilirubin, creatinine, creatine kinase (CPK), alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), glutamyltransferase (γ-GT), magnesium, sodium, potassium, chlorine, total calcium, inorganic phosphorus, lactate dehydrogenase (LDH), glucose, uric acid, triglyceride (TG); and list all the result.
Adverse events of single dose
Time frame: Up to 3 weeks
The adverse events are encoded using MedDRA 20.1. According to system organ classification (SOC) and preferred term (PT), all TEAE, investigational drug-related TEAE, Serious Adverse Event, investigational drug-related SAE, and TEAE causing premature withdrawal from this study will be separately summarized by different dose groups, including number of subjects experiencing Adverse Event, percentage and number of AE cases. The summary results are sorted according to the ranking number of cases of all subjects experiencing AE. All AE and SAE are listed by different dose groups.
Physical examination value of multiple doses
Time frame: Baseline to Day 21 after receiving the first dose
The measure is a composite. Evaluate safety and tolerability of multiple doses in Physical examination that should cover the head, eyes, ears, nose, throat, cardiovascular system, skin, musculoskeletal, respiratory system, digestive system, urinary system and nervous system and changes of each item from the baseline are summarized. The measurement results of each subject are summarized by different severity. All physical examination results during this trial will be listed in details.
Vital signs value of multiple doses
Time frame: Baseline to Day 21 after receiving the first dose
The measure is a composite.Evaluate safety and tolerability of multiple doses in Vital signs value that including blood pressure(Systolic blood pressure/Diastolic blood pressure), pulse, body temperature.Each vital sign examination values at each evaluation time point and their changes relative to the baseline will be summarized. All vital sign results should be listed. The listed vital signs are compared with normal ranges to determine whether is abnormal. The examination results that are divided into higher than normal range, normal and lower than normal range will be summarized by number of cases (n) and percentage (%). The results of abnormalities(> or < normal range) are listed.
12-lead ECG value of multiple doses
Time frame: :Baseline to Day 21 after receiving the first dose
Evaluate safety and tolerability of multiple doses in 12-lead ECG value that including ventricular rate (beats/min) ，PR interval (ms)， QRS (ms) ,，QT(ms)， QT interval (QTc )(ms). The examination results of each ECG parameters and their changes from baseline will be summarized at each time point. Meanwhile, all 12-lead ECG examination results will be listed in details.
Blood routine value of multiple doses
Time frame: Baseline to Day 21 after receiving the first dose
Evaluate safety and tolerability of multiple doses in blood routine value that including White blood cells (WBC), red blood cells (RBC), hemoglobin (Hb), hematocrit (Hct), platelet, neutrophils, lymphocytes, monocytes, eosinophils, basophils, absolute neutrophil counts (ANC); and list all the result.
Urine routine value of multiple doses
Time frame: Baseline to Day 21 after receiving the first dose
Evaluate safety and tolerability of multiple doses in urine routine value that including specific gravity, potential of hydrogen (pH), proteins, ketone,occult blood; and list all the result.
Blood coagulation value of multiple doses
Time frame: Baseline to Day 21 after receiving the first dose
Evaluate safety and tolerability of multiple doses in blood coagulation value that including International normalized ratio (INR), activated partial thromboplastin time (aPTT), prothrombin time (PT);
Blood biochemistry value of multiple doses
Time frame: Baseline to Day 21 after receiving the first dose
Evaluate safety and tolerability of multiple doses in blood biochemistry value that including Cholesterol, total proteins, albumin, total bilirubin, Conjugated bilirubin, creatinine, creatine kinase (CPK), alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), glutamyltransferase (γ-GT), magnesium, sodium, potassium, chlorine, total calcium, inorganic phosphorus, lactate dehydrogenase (LDH), glucose, uric acid, triglyceride (TG); and list all the result.
Adverse events of multiple doses
Time frame: Up to 6 weeks
The adverse events are encoded using MedDRA 20.1. According to system organ classification (SOC) and preferred term (PT), all treatment-emergent adverse event (TEAE), investigational drug-related TEAE, serious adverse event (SAE), investigational drug-related SAE, and TEAE causing premature withdrawal from this study will be separately summarized by different dose groups, including number of subjects experiencing AE, percentage and number of adverse event (AE) cases. The summary results are sorted according to the ranking number of cases of all subjects experiencing AE. All AE and SAE are listed by different dose groups.
20 secondary outcomes
Pharmacokinetic parameter of major metabolite(M1): Cmax
Time frame: 72 h after receiving single oral doses
Pharmacokinetic parameter of major metabolite(M1): Tmax
Time frame: 72 h after receiving single oral doses
Pharmacokinetic parameter of major metabolite(M1): T1/2
Time frame: 72 h after receiving single oral doses
Pharmacokinetic parameter of major metabolite(M1): Kel
Time frame: 72 h after receiving single oral dose
Pharmacokinetic parameter of major metabolite(M1): MRT
Time frame: 72 h after receiving single oral dose
Pharmacokinetic parameter of major metabolite(M1): AUC 0-24h
Time frame: 24 h after receiving single oral dose
Pharmacokinetic parameter of major metabolite(M1): AUC 0-last
Time frame: 72 h after receiving single oral dose
Pharmacokinetic parameter of major metabolite(M1): AUC 0-inf
Time frame: 72h after receiving single oral dose
Pharmacokinetic parameter of major metabolite(M1): CL/F
Time frame: 72h after receiving single oral dose
Pharmacokinetic parameter of major metabolite(M1): Vd/F
Time frame: 72h after receiving single oral dose
Pharmacokinetic parameter of major metabolite(M1): Css, min
Time frame: :predose at day 8, 9, and 10, 72 h after receiving last multiple oral doses
Pharmacokinetic parameter of major metabolite(M1): Css, max
Time frame: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter of major metabolite(M1): Css, av
Time frame: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter of major metabolite(M1): Tss, max
Time frame: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter of major metabolite(M1): Vss/F
Time frame: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter of major metabolite(M1): tss,1/2
Time frame: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter of major metabolite(M1): CLss/F
Time frame: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter of major metabolite(M1): DF
Time frame: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter of major metabolite(M1): AUCss
Time frame: 72 h after receiving last multiple oral doses
Pharmacokinetic parameter of major metabolite(M1): Rac
Time frame: 72 h after receiving last multiple oral doses
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Zhang, Doctor principal investigator
Chief technician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LXI-15028 50mg, LXI-15028 100mg and LXI-15028 200mg in people with Healthy, run by Shandong Luoxin Pharmaceutical Group Stock 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 23 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 30 May 2018. 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?
Pharmacokinetic parameter： Cmax (time frame: 72 h after receiving single oral dose). The study lists 34 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2018.