Status:
COMPLETED
Safety and Pharmacokinetics of JAK/ROCK Inhibitor in Healthy Volunteers
Lead Sponsor:
Celon Pharma SA
Collaborating Sponsors:
National Center for Research and Development, Poland
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The aim of the following clinical trial is to determine safety an pharmacokinetic parameters in healthy volunteers after oral administration of Janus kinases and Rho-kinases inhibitor (JAK/ROCKi), cal...
Detailed Description
The following clinical trial consists of two phases IA and IB. Approximately 68 volunteers who meet all the inclusion and none of the exclusion criteria are going to be enrolled into the study. Phase ...
Eligibility Criteria
Inclusion
- Body-mass index (BMI): ≥ 18.5 kg/m² and \< 29.9 kg/m²,
- Physical examination (such as observation, palpation, percussion and auscultation) without any clinically relevant abnormality,
- Clinical laboratory results in hematology or renal/hepatic test and clinical laboratory results in other tests without any clinically relevant abnormalities as assessed by Investigator,
- Non-smoker and non-user of tobacco products for at least 3 months before screening,
- Subject able to provide written informed consent after receiving information about the trial,
- Informed Consent Form signed and dated prior to Screening evaluations,
- Ability and willingness to comply with the requirements of the study protocol,
- Volunteer (or his/her partner) of childbearing potential willingness to use acceptable forms of contraception: complete abstinence from sexual intercourses or barrier method of spermicide (condom, diaphragm) or intrauterine device or hormonal contraceptive since at least screening evaluations for male volunteers and since at least 4 weeks before screening for female volunteers. Volunteers are furthermore willing to use it for 90 days (males) or 30 days (females) after examination at the end of the study.
- Negative result of the COVID-19 RT-PCR test (real-time reverse transcription polymerase chain reaction) for the qualitative detection of nucleic acid from SARS- CoV-2 before inclusion to the study.
Exclusion
- Subject with known allergy, hypersensitivity, intolerance or contraindication to other drugs similar in structure or class to CPL409116 compound, or to any excipients of the formulation,
- Any known significant current or past acute or chronic disease or condition of the: circulatory, respiratory, hematopoietic, endocrine, nervous and musculoskeletal system, alimentary and urinary tracts, allergic disease, genetic or psychiatric disorder, thromboembolism in a volunteer or in members of their close family that could influence the present general health condition, at the Investigator's discretion,
- Thrombophilia or genetic predisposition to thrombophilia in a volunteer and/or previous or current thromboembolic events/ disease in a volunteer or in members of their family,
- Subject has a long QT interval analysis syndrome or is under the treatment with antiarrhythmic drugs,
- Current disease of the alimentary tract, liver or kidneys that may influence absorption, distribution and/or elimination of the studied drug, as assessed by the Investigator and documented in the medical history,
- Medical condition that requires administration of other drugs or use of any drug within the 4 weeks preceding the first IMP administration and during the entire study. Drugs commonly used with fast metabolism may be administered and is up to Investigator discretion (i.e. pain killers),
- Participation in other clinical trials, where at least one dose of study drug was administered, within 90 days preceding the screening phase,
- Blood drawn within 30 days prior to inclusion in this study (more or equal to 300 mL),
- Positive results from pregnancy test in female volunteers,
- Lactation in female volunteers,
- Hypotension or hypertension in medical history, on Screening Day or before treatment period, if Principal Investigator is to assess it as clinically relevant,
- Narcotic and alcohol addiction or abuse (more than 14 alcohol units per week: one unit = 150 mL wine, 360 mL beer, 45 mL 40 % spirits) (UK guidelines),
- Positive results of HBsAg, anti-HCV or anti-HIV tests,
- Positive drug screen or alcohol breath tests,
- Subjects who adhere to a special diet (e.g. low calories, vegetarian, etc.),
- The subject is considered by the Investigator to be an unsuitable candidate to participate in the study for any reason.
Key Trial Info
Start Date :
December 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2021
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04670757
Start Date
December 8 2020
End Date
September 8 2021
Last Update
May 16 2022
Active Locations (1)
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1
BioResearch Group Sp. z o.o.
Kajetany, Nadarzyn, Poland, 05-830