Clinical trial NCT06636500: A Phase 1 Study of CG001419 Administered Orally in Healthy Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteer Study
Pain Management
Lead sponsor: Cullgen Australia Pty Ltd
Sponsor class: INDUSTRY
First posted: 2024-10-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo-Controlled
Primary purpose: TREATMENT

Brief summary: This is a dose finding study of CG001419, administered as a single dose, with or without food, and as multiple doses. CG001419 is being tested in healthy volunteers in this trial with the goal of eventually developing the drug for patients with pain if it is found to be safe and well tolerated.


Eligibility criteria: 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:

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  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).

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.

Primary outcomes:
measure: To evaluate the safety and tolerability of single and multiple ascending oral doses of CG001419 in healthy subjects
timeFrame: Up to 7 days of dosing
Secondary outcomes:
measure: To further characterize the PK of CG001419 in healthy subjects
timeFrame: Up to 7 days of dosing
measure: To further characterize the PK of CG001419 in healthy subjects
timeFrame: Up to 7 days of dosing
measure: To further characterize the PK of CG001419 in healthy subjects
timeFrame: Up to 7 days of dosing
measure: To further characterize the PK of CG001419 in healthy subjects
timeFrame: Up to 7 days of dosing
measure: To further characterize the PK of CG001419 in healthy subjects
timeFrame: Up to 7 days of dosing
measure: To further characterize the PK of CG001419 in healthy subjects
timeFrame: Up to 7 days of dosing
measure: To further characterize the PK of CG001419 in healthy subjects
timeFrame: Up to 7 days of dosing
measure: To further characterize the PK of CG001419 in healthy subjects
timeFrame: Up to 7 days of dosing
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX Clinical Research
state: South Australia
Study officials:
References: