Safety and Pharmacokinetics Study of CPL207280 Compound in Healthy Volunteers.

• Status: Completed
• Trial end date: 2021-05-05
• Target enrollment: 0
• Participant gender: All

Summary

The planned study is to determine the safety and pharmacokinetic properties of CPL207280 compound after single and multiple (two weeks) administration in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Celon Pharma SA
• Collaborator: National Center for Research and Development, Poland
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Caucasian female or male

• Body-mass index (BMI): ≥ 18.5 kg/m² and < 29.9 kg/m²,

• Physical examination 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.

Exclusion Criteria:

• Known allergy, hypersensitivity, intolerance or contraindication to other drugs similar in structure or class to CPL207280 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 that could influence the present general health condition, at the Investigator's discretion,

• A long QT interval analysis syndrome (in the interview) 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,

• Narcotic and alcohol addiction or abuse,

• 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.).