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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06636500




Registration number
NCT06636500
Ethics application status
Date submitted
8/10/2024
Date registered
10/10/2024

Titles & IDs
Public title
A Phase 1 Study of CG001419 Administered Orally in Healthy Subjects
Scientific title
A Phase 1, Single and Multiple Ascending Dose and Food Effect Study of CG001419 Administered Orally to Evaluate Safety, Tolerability and Pharmacokinetics in Healthy Subjects
Secondary ID [1] 0 0
CG001419-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteer Study 0 0
Pain Management 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CG001419
Treatment: Drugs - Placebo

Experimental: CG001419 - Part A: Single ascending dose cohorts; food effect cohort; Part B: Multiple ascending dose cohorts

Placebo comparator: Placebo - Part A: Single ascending dose cohorts; Part B: Multiple ascending dose cohorts


Treatment: Drugs: CG001419
Oral doses

Treatment: Drugs: Placebo
Oral doses
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety and tolerability of single and multiple ascending oral doses of CG001419 in healthy subjects
Timepoint [1] 0 0
Up to 7 days of dosing
Secondary outcome [1] 0 0
To further characterize the PK of CG001419 in healthy subjects
Timepoint [1] 0 0
Up to 7 days of dosing
Secondary outcome [2] 0 0
To further characterize the PK of CG001419 in healthy subjects
Timepoint [2] 0 0
Up to 7 days of dosing
Secondary outcome [3] 0 0
To further characterize the PK of CG001419 in healthy subjects
Timepoint [3] 0 0
Up to 7 days of dosing
Secondary outcome [4] 0 0
To further characterize the PK of CG001419 in healthy subjects
Timepoint [4] 0 0
Up to 7 days of dosing
Secondary outcome [5] 0 0
To further characterize the PK of CG001419 in healthy subjects
Timepoint [5] 0 0
Up to 7 days of dosing
Secondary outcome [6] 0 0
To further characterize the PK of CG001419 in healthy subjects
Timepoint [6] 0 0
Up to 7 days of dosing
Secondary outcome [7] 0 0
To further characterize the PK of CG001419 in healthy subjects
Timepoint [7] 0 0
Up to 7 days of dosing
Secondary outcome [8] 0 0
To further characterize the PK of CG001419 in healthy subjects
Timepoint [8] 0 0
Up to 7 days of dosing

Eligibility
Key inclusion criteria
* Cis-male and cis-female subjects must be 18-65 years, inclusive, at the time of signing the informed consent form (ICF).
* Subjects who are in good general health according to the judgment of the investigator per local guidance, eg, with no clinically relevant abnormalities based on medical history, physical examinations, neurological examinations, clinical laboratory evaluations (hematology and clinical chemistry), vital signs, and 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, would affect subject safety.
* Subjects who have a body mass index (BMI) of 18-32 kg/m2 (inclusive) at screening.
* Male subjects are eligible to participate if they are permanently sterile by vasectomy (at least 6 months), or agree to the following during the study and for at least 90 days after the last dose of study drug:

1. Refrain from donating sperm

AND, either:
2. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR
3. Agree to use a male condom (contraception/barrier) and should also be advised of the benefit for a female partner to use an acceptable, highly effective method of contraception (of low user dependency or is user dependent), as a condom may break or leak when having sexual intercourse 5. Female subjects are eligible to participate if they are not pregnant or breastfeeding and fall under 1 of the following criteria:

<!-- -->

1. Women of childbearing potential (WOCBP), defined as women physiologically capable of becoming pregnant, must have a negative serum pregnancy test at the Screening visit and a negative urine pregnancy test on Day -1; WOCBP must agree to be abstinent from heterosexual intercourse or use an acceptable, highly effective contraceptive method (of low user dependency or is user dependent) from Screening and not donate eggs until 30 days after the last dose of the study drug.

OR
2. Menopausal women must have an elevated serum follicle-stimulating hormone level (FSH >40 IU/mL) level at Screening; if the FSH is not elevated, they are considered to be of childbearing potential (unless permanently sterile).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Clinically significant infection and/or cardiovascular, hematological, renal, hepatic, pulmonary (except recovered childhood asthma), endocrine, reproductive, gastrointestinal, immunological, dermatological, neurological (except migraine), or psychiatric (except depression, which was potentially medicated in the past but didn't require hospitalization) diseases, which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the investigator, unacceptably increase the subject's risk if he/she were to participate in the study.
* History of neuropathy and/or any neurosensory symptoms in the feet or hands.
* Unable to ingest a high-fat meal, such as those who are lactose intolerant (only for subjects in the FE part and if recommended, MAD part too)
* History of disorders that affect gastrointestinal transit time (eg, short bowel syndrome, gastroparesis, irritable bowel syndrome, inflammatory bowel diseases, history of gastric bypass
* Use of prescription drugs, over-the-counter drugs (other than acetaminophen and ibuprofen), herbal medications, or vitamin supplements within 7 days or 5 half-lives, whichever is longer, prior to dosing and antibiotics and systemic steroids within 30 days prior to dosing. Oral contraceptives are permitted. The sponsor, after consulting medical monitor may allow exceptions only if the medication's administration is deemed unlikely to impact the PK results.
* Past or current history or evidence of drug or alcohol abuse, alcohol consumption exceeding 5 units of alcohol on an average per day (1 unit of alcohol = 150 mL of wine, 360 mL of beer, or 45 mL of alcohol 40%). Use of any non-marijuana illicit drugs (e.g., cocaine, phencyclidine) within 6 months of Screening.
* Donation of over 500 mL of blood within 8 weeks prior to Screening.
* In the opinion of the investigator the subject is unlikely to comply with the study procedures, restrictions, and requirements and is not suitable for entry into the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cullgen Australia Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Satya Das, MD, MSCI
Address 0 0
Country 0 0
Phone 0 0
(858) 284-0115
Fax 0 0
Email 0 0
nanu.das@cullgen.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a healthy volunteer study being conducted to define the safety profile of the drug. This study is not exploring the activity of our drug in the target indication population (patients with pain). As such, we do not believe there is utility for sharing deidentified IPD from this trial with other researchers.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06636500