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Safety and Tolerability of CFTX-1554 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05260658
Recruitment Status : Recruiting
First Posted : March 2, 2022
Last Update Posted : August 5, 2022
Sponsor:
Information provided by (Responsible Party):
Confo Therapeutics

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 (Part B).

Part A will have a randomized, double-blind, placebo-controlled design. Subjects will receive single ascending doses of CFTX-1554 or placebo (as liquid formulation under fasted condition) in 7 subsequent cohorts. Drug intake under fed conditions, and as capsule under fasted conditions and under fed conditions (Periods 2 to 4), compared to liquid formulation under fasted conditions (Period 1) (1 single dose level only) will be assessed.

Part B will have a randomized, double-blind, placebo-controlled design, assessing multiple ascending oral doses of CFTX-1554 or placebo in 4 subsequent cohorts.


Condition or disease Intervention/treatment Phase
Healthy Drug: CFTX-1554 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of CFTX-1554 in Healthy Subjects, With Comparison of Intake of CFTX-1554 as Liquid Formulation and as Capsule, and After a High-fat Breakfast Versus Fasted
Actual Study Start Date : February 28, 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: Part A: CFTX-1554 Single Ascending Dose (SAD)
Up to 7 dose levels with CFTX-1554 administered as oral liquid formulation under fasted conditions (at 1 single dose level only, drug intake under fed conditions, and as capsule under fasted conditions and under fed conditions, will be assessed)
Drug: CFTX-1554
CFTX-1554 is a new chemical entity that binds to the angiotensin II type 2 receptor (AT2R).

Placebo Comparator: Part A placebo
Single placebo administration in study Part A
Drug: Placebo
CFTX-1554 matching placebo

Experimental: Part B: CFTX-1554 Multiple Ascending Dose (MAD)
Up to 4 dose levels with CFTX-1554 in Part B. Doses and dosing frequency will be decided based on the results of study Part A.
Drug: CFTX-1554
CFTX-1554 is a new chemical entity that binds to the angiotensin II type 2 receptor (AT2R).

Placebo Comparator: Part B placebo
Multiple placebo administration in study Part B
Drug: Placebo
CFTX-1554 matching placebo




Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: Day -1 through Day 13 (Single Ascending Dose study part) or Day 26 (Multiple Ascending Dose study part) ]
    Number of Participants With Adverse Events Following Oral Administration of CFTX-1554 in SAD (Part A) and MAD (Part B)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05260658


Contacts
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Contact: Maarten Van Roy, PhD +3293967400 clinicaltrials@confotherapeutics.com

Locations
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Netherlands
PRA Health Sciences Recruiting
Groningen, Netherlands, 9728
Sponsors and Collaborators
Confo Therapeutics
Investigators
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Study Chair: Paolo Vicini, PhD Confo Therapeutics
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Responsible Party: Confo Therapeutics
ClinicalTrials.gov Identifier: NCT05260658    
Other Study ID Numbers: CFTX1554-C101
2021-006368-26 ( EudraCT Number )
First Posted: March 2, 2022    Key Record Dates
Last Update Posted: August 5, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No