A phase 1 study to evaluate the safety, tolerability and pharmacokinetics of a ginger tincture extract in healthy volunteers.
- Conditions
- Rheumatoid ArthritisInflammatory and Immune System - Rheumatoid arthritis
- Registration Number
- ACTRN12624000125527
- Lead Sponsor
- Evithé Biotechnology Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
1.Male or female between 18 and 55 years of age, inclusive, at the time of screening.
2.The participant weighs more or equal to 50 kg and has a body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive at screening.
3.Participants must be in good physical and mental health as determined by absence of clinically significant (in the opinion of the Investigator) abnormalities based on a medical evaluation including review of medical history, physical examination, safety laboratory tests, vital signs, and 12-lead ECG monitoring at screening and prior to first administration of study treatment on Day 1. Potential participants with a history of childhood asthma (resolved), depression (non-hospitalised, but potentially medicated in the past) and migraine may be considered for study participation. A potential participant with a clinical abnormality or laboratory parameters outside the normal reference range for the population being studied may be re-tested once, at the Investigator’s discretion, and may be included only if the Investigator considers that the finding/s are unlikely to introduce additional risk factors and will not interfere with the study procedures.
Note: The Investigator must first consult the local MM prior to enrolling such a participant, and the local MM will inform the Sponsor as required. All such discussions and the outcomes must be documented.
4.Normal vital signs after more or equal to 5 minutes resting in supine position:
a.Greater than 90 mmHg and less than 160 mmHg systolic blood pressure (SBP)
b.Greater than 40 mmHg and less than 100 mmHg diastolic blood pressure (DBP)
c.Greater than 40 bpm and less than 100 bpm heart rate
d.Body temperature less than or equal to 37.7°C
5.Standard 12-lead ECG parameters after more or equal to 5 minutes resting in supine position with PR greater than 120 msec and less than 220 msec, QRS less than 120 msec, QTcF less than or equal to 450 msec for males and less than or equal to 470 msec for females, and otherwise normal ECG.
6.Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or use highly effective contraceptive method (oral contraceptive pills [OCPs], long-acting implantable hormones, injectable hormones, a vaginal ring or an intrauterine device [IUD]) from screening until study completion, including the follow up period for at least 30 days after the last dose of study treatment, or be post-menopausal for greater than or equal to 12 months. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels (greater than or equal to 25 IU/L) at screening for amenorrheic female participants. Female participants whose only partner has had a vasectomy, and female participants who are abstinent from heterosexual intercourse as part of their usual lifestyle will also be eligible for participation.
7.Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to administration of the first dose of study treatment on Day 1 and be willing to have additional pregnancy tests as required throughout the study.
8.Males must be surgically sterile (more than 30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a WOCBP, the male participant and his partner must be surgically sterile (e.g., tubal occlusio
1.The participant has uncontrolled, clinically significant neurologic (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, or endocrine disease, psychiatric disorder, or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results. It is the responsibility of the Investigator to assess the clinical significance; however, consultation with the MM may be warranted.
2.There is any finding in the participant’s medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking Carelwon, or that might interfere with the conduct of the study.
3.Impaired hepatic function as indicated by screening aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to 2 or total bilirubin greater than or equal to 1.5 x upper limit of normal (ULN), which remains above these limits if re-tested.
4.Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of known Gilbert's syndrome or asymptomatic gallstones).
5.Any cardiac/QT risk i.e.
a.Family history of sudden death or of congenital prolongation of the QTc interval or known congenital prolongation of the QTc interval or any clinical condition known to prolong the QTc interval.
b.History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia.
c.Electrolyte disturbances, particularly hypokalaemia, hypocalcaemia, or hypomagnesaemia.
d.ECG abnormalities in the standard 12-lead ECG (at screening) which in the opinion of the Investigator is clinically relevant or will interfere with the ECG analyses on study.
6.The participant has current or recent (within 6 months) gastrointestinal condition that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, oesophageal reflux, peptic ulcer disease, erosive oesophagitis, frequent [more than once per week] occurrence of heartburn, and/or any surgical intervention).
7.The participant has a history of cancer, except basal cell carcinoma or in situ cervical cancer that has been in remission for more than or equal to 5 years prior to first dose of study treatment.
8.Any prior allergies to ginger or ginger-containing products or the participant has a known hypersensitivity to any component of the Carelwon formulation.
9.Consumption of any ginger-containing products within 48 hours or 5 half-lives of those products prior to Day 1 and until completion of the last onsite visit (7 days after last administered dose of study treatment). Participant must abstain from ginger-containing foods which may include: curry dishes with ginger paste, gingerbread, muffins, Chinese stir fry, sushi, soups, apple cake, ginger tea, ginger juice, ginger beer, ginger ale, ginger candy, ginger-containing cocktails, ginger chutney, ginger murabba, ginger cookies, food cooked with ginger seasoning.
10.Participant has a diagnosed bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with blood draws or is unable to provide a blood sample without undue trauma or distress, or has poor peripheral venous access and is unsuitable for cannulation or repeated venipuncture.
11.The participant has any dietary restrictions or preferences tha
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method