Healthy Volunteers
Conditions
Brief summary
This study is designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamic effects of an investigational drug (CHK-336) when administered to healthy volunteers.
Interventions
DRUGCHK336
Tablet
DRUGPlacebo
Tablet
Sponsors
Chinook Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy volunteers must meet all the following inclusion criteria to be randomized: 1. Male and female adults18 to 45years old, inclusive, at the time of consent. 2. Body mass index (BMI) between 19 and 32 kg/m2, inclusive, (between 30.0 and \< 40.0 kg/m2 for SAD Cohort A8) at screening. 3. Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. All participants (male or female) who are of childbearing potential must agree to use highly effective contraception during the study. Female participants must continue to use highly effective contraception during the study for 30 days after the last dose of study drug. Female participants should not donate oocytes during this time. Male participants with female partners of childbearing potential must continue to use highly effective contraception during the study and for 90 days after the last dose of study drug. Male participants must agree not to donate sperm during this time. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant. 4. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and Day -3 as well as a negative urine pregnancy test at Day 1 (predose). WOCBP must agree to undergo a pregnancy test during the study 5. Female participants not of childbearing potential must be either surgically sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) or postmenopausal, defined as no menses for 12 months without an alternative medical cause, with follicle-stimulating hormone (FSH) in the postmenopausal range at screening, based on the central laboratory's ranges. 6. Willing and able to provide informed consent and comply with all study visits and procedures including overnight stays in the clinic 7. Willing and able to comply with a pre-specified diet at least 72 hours prior to dose and throughout the study. 8. Negative urine drug, tobacco, and breath alcohol test result at screening and Day-3. 9. Have not used any nicotine-containing product within 3 months prior to the first study drug administration and who are willing to abstain throughout the study.
Exclusion criteria
Healthy volunteers must not meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety and tolerability of single ascending doses and multiple ascending doses of CHK-336 in HV | Up to 28 days | Incidence, nature, and severity of adverse events (AEs), adverse events of special interest (AESI), and serious adverse events (SAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic measure of Tmax | Up to 17 days | Time to maximum observed concentration of CHK-336 in plasma under fasted or fed condition |
| Pharmacokinetic measure of AUC (0-∞) | Up to 17 days | The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of CHK-336 in plasma under fed or fasted condition |
| Pharmacokinetic measure of AUC for up to 24 hours (AUC0-24) | up to 17 days | The area under the concentration-time curve from time zero extrapolated to 24 hours post dose (AUC0-24) in plasma under fed or fasted condition |
| Pharmacokinetic measure of AUC for up to last measurable time point (AUC0-T) | up to 17 days | The area under the concentration-time curve from time zero extrapolated to last measurable timepoint (AUC0-T) of CHK-336 in plasma under fed or fasted condition |
| Pharmacokinetic measure of Cmax | Up to 17 days | Maximum observed concentration of CHK -336 in plasma under fasted or fed condition |
| Pharmacokinetic measure of exposure accumulation ratios of CHK-336 | up to 17 days | The exposure accumulation defined as the ratio of last dose to single dose AUC0-24h with once a day dosing |
| Pharmacokinetic measure of exposure accumulation ratios (Cmax) for CHK-336 | up to 17 days | The exposure accumulation defined as the ratio of last dose to single dose Cmax with once a day dosing |
| Pharmacokinetic measure of the amount of CHK-336 excreted in urine | Up to 24 hours | Measure the amount of CHK-336 excreted in urine under fasted condition |
| Pharmacokinetic measure of apparent terminal half-life (t1/2) | up to 17 days | Apparent terminal half-life (t1/2) of CHK-336 in plasma under fasted or fed condition |
Countries
United States
Outcome results
None listed