Safety and Pharmacokinetics Study of CPL207280 Compound in Healthy Volunteers.

Celon Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: CPL207280; Drug: Metformin hydrochloride 750 mg; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04622111

01GPR2019

Details and patient eligibility

About

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

Full description

This is to be one-centre, single ascending dose and double-blind multiple ascending dose two part study of CPL207280 compound in healthy volunteers. PART A is a single dose, open-label part with CPL207280 compound administered with dose escalation between cohorts.Additionaly assessing the effect of food and effect of metformin on bioavailability of CPL207280 is to be done in additional cohort. PART B is a multiple, double-blind part with CPL207280 compound administered for 14 days with dose escalation between cohorts. Participants in this part are to be randomized to receive Investigational Medicinal Product (IMP) or placebo in 3:1 ratio. Safety and pharmacokinetic properties of CPL207280 compound is to be determined following different doses in single oral IMP administration in PART A and different doses of IMP administered orally for two weeks in PART B.

Enrollment: 68 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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68 participants in 3 patient groups, including a placebo group

CPL207280

Experimental group

Description:

PART A: 8 cohorts are to receive single dose of IMP.Each participant is to take single dose of IMP. There is to be dose escalation between cohorts. PART B: 4 cohorts are to receive multiple dose of IMP. Each participant is to take IMP once daily for 14 days. There is to be dose escalation between cohorts.

Treatment:

Drug: CPL207280

Placebo

Placebo Comparator group

Description:

PART B: 2 Participants from each of 4 cohorts (total of 8 participants) are to receive masking placebo tablet once daily for 14 days. There is to be dose escalation between cohorts. Participants are to be randomized within cohorts.

Treatment:

Drug: Placebo

CPL207280 120 mg + Metformin 750 mg

Experimental group

Description:

1 cohort (total of 12 participants) are to receive single dose of IMP in fed and fasted state, IMP with metformin and metformin alone to assess the effect of food and metformin on bioavailability of CPL207280. There is to be one week wash-out between four treatments periods for this cohort.

Treatment:

Drug: CPL207280

Drug: Metformin hydrochloride 750 mg