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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05202379
Other study ID # CC-42344-P1-001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 11, 2022
Est. completion date March 29, 2023

Study information

Verified date May 2023
Source Cocrystal Pharma, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

CC-42344 Phase 1 study with single-ascending dose (SAD) and multiple-ascending dose (MAD) parts.


Description:

This study is testing the safety, tolerability, and pharmacokinetics (PK, the amount of study drug in the blood) of a new drug called CC-42344.Up to 78 healthy men or women aged between 18-55 are planned to be enrolled in this study in two parts. Part 1 will involve a single-ascending (increasing) dose (SAD) where 32 participants (4 groups of 8) will be assigned randomly to receive a single oral dose of the study drug or placebo. The placebo will look the same as the study drug but will not contain any medicine. An additional 6 participants will receive a single oral dose of CC-42344 to help further understand the effect of food on the uptake of the drug. Part 2: will involve a multiple-ascending dose (MAD) where 40 participants (5 groups of 8) will be randomized to receive an oral dose of study drug or placebo given once a day for 14 days, once a day for 5 days, or twice a day for 5 days. The placebo will look the same as the study drug but will not contain any medicine.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date March 29, 2023
Est. primary completion date March 29, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria (main): - Healthy males or healthy, non-pregnant, non-lactating females - Body weight of at least 50 kg - Body mass index between =18.0 and =32.0 kg/m2 - Good state of health (mentally and physically) - Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test, if required and per site policy Exclusion Criteria (main): - Have received any investigational drug in a clinical research study within the previous 30 days before screening - Have received any vaccine within 7 days prior to randomization - History of any drug or alcohol abuse in the past 2 years - Females of childbearing potential who are pregnant or lactating or planning to become pregnant during the study - Clinically significant abnormal biochemistry, hematology, coagulation, or urinalysis as judged by the investigator

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CC-42344
CC-42344 capsules
Placebo
Placebo capsules

Locations

Country Name City State
Australia Linear Clinical Research Nedlands Western Australia

Sponsors (3)

Lead Sponsor Collaborator
Cocrystal Pharma, Inc. Cocrystal Pharma Australia Pty Ltd., Linear Clinical Research

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary treatment emergent adverse events number of participants with treatment-emergent adverse events Day 1 to 7 days after last dose
Primary laboratory abnormalities number of participants with clinically significant laboratory abnormalities Day 1 to 7 days after last dose
Primary vital signs number of participants with clinically significant changes from baseline in vital signs Day 1 to 7 days after last dose
Primary ECG number of participants with clinically significant changes from baseline in ECGs Day 1 to 7 days after last dose
Secondary maximum plasma concentration measurement of maximum plasma concentration (Cmax) Day 1 to 7 days after last dose
Secondary time of maximum plasma concentration measurement of time of maximum plasma concentration (Tmax) Day 1 to 7 days after last dose
Secondary area under the plasma concentration-time curve measurement of area under the plasma concentration-time curve (AUC) Day 1 to 7 days after last dose
Secondary elimination rate constant measurement of elimination rate constant Day 1 to 7 days after last dose
Secondary terminal elimination half-life measurement of terminal elimination half-life (t1/2) Day 1 to 7 days after last dose
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