Status:
COMPLETED
Safety and Tolerability of CFTX-1554 in Healthy Subjects
Lead Sponsor:
Confo Therapeutics
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The study will consist of 2 parts, i.e. a single ascending dose part with integrated food effect assessment and assessment of relative bioavailability (Part A), and a multiple ascending dose part (Par...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Body mass index 18.0 to 30.0 kg/m2
- Females may be of childbearing potential but not pregnant or lactating, or of nonchildbearing potential; all females will be required to have a negative serum pregnancy test conducted at screening, (each) admission, and follow-up.
- Female subjects of childbearing potential who have a fertile male sexual partner must agree to use adequate contraception from at least 4 weeks prior to first administration of study drug until 90 days after the follow up visit.
- Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from first admission to the clinical research center until 90 days after the follow-up visit.
- All prescribed medication must have been stopped at least 30 days prior to first admission to the clinical research center.
- All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications must have been stopped at least 14 days prior to first admission to the clinical research center.
- Ability and willingness to abstain from alcohol from 48 hours before screening and first admission to the clinical research center.
- Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) and grapefruit (juice) from 48 hours before first admission to the clinical research center.
- Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.
- Willing and able to sign the Informed Consent Form.
- EXCLUSION CRITERIA:
- Previous participation in the current study
- History of relevant drug and/or food allergies
- Allergy or hypersensitivity to active ingredient or excipients of the study drug
- Using nicotine-containing products within 60 days prior to the first study drug administration
- History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 1 year before screening
- Positive drug and alcohol screen in urine (opiates, methadone, cocaine, amphetamines \[including ecstasy\], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, nicotine metabolites \[cotinine\], and alcohol) at screening or at one of the admissions to the clinical research center
- Average intake of \>24 units of alcohol/week
- Positive screen for hepatitis B surface antigen, hepatitis C virus antibodies, or human immunodeficiency virus 1 and 2 antibodies
- Participation in a drug study within 30 days prior to the first study drug administration in the current study (counting from the follow-up visit to the screening visit). Participation in ≥4 other drug studies in the 12 months before the first study drug administration in the current study
- Donation or loss of \>450 mL of blood within 60 days pribefore the first study drug administration. Donation or loss of \>1.5 L of blood in male subjects) or \>1.0 L of blood in female subjects in the 10 months before the first study drug administration in the current study.
- Significant and/or acute illness within 5 days before the first study drug administration that may impact safety assessments, in the opinion of the Investigator.
- Unwillingness to consume the Food and Drug Administration (FDA) breakfast or intolerance to any of the ingredients of the FDA breakfast (Cohort A5 only)
- Vaccination against SARS-CoV-2 planned between 2 weeks before first admission and follow-up.
- Positive nasopharyngeal PCR test for SARS-CoV-2 on Day -1, or any known contact with a person who tested positive for SARS-CoV-2 or with a COVID 19 patient within 2 weeks before admission.
Exclusion
Key Trial Info
Start Date :
February 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2023
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT05260658
Start Date
February 9 2022
End Date
February 10 2023
Last Update
September 5 2023
Active Locations (1)
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1
PRA Health Sciences
Groningen, Netherlands, 9728