Congenital Adrenal Hyperplasia (CAH)
Conditions
Brief summary
The goal of this study is to explore the safety, drug concentrations and effects on adrenal gland hormones after a single dose or multiple doses of OMS1620 in healthy participants. In addition, the effect of food on drug concentrations will also be tested.
Interventions
DRUGOMS1620
OMS1620 is an oral small molecule antagonist of the melanocortin 2 receptor (MC2R), the receptor for adrenocorticotrophic hormone (ACTH)
DRUGPlacebo
matched placebo control for OMS1620
Sponsors
OMass Therapeutics Australia Proprietary Ltd
OMass Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Body mass index (BMI) 18.0 to 32.0 kg/m2 (inclusive) and weight ≥45.0 kg * Females must be either postmenopausal, surgically sterile or consistently use highly effective methods of contraception from 30 days prior to Day -1 until at least 30 days after the end of the study. * Females must not be pregnant or lactating * Males participants who are sexually active with female partners who are females of childbearing potential must use at least two medically effective methods of contraception from Screening through 90 days after the last dose of study drug * Medically healthy with no significant medical history, physical examination, laboratory, vital signs, or ECG findings, as deemed by the Investigator or qualified designee Key
Exclusion criteria
* Use of systemic glucocorticoid therapies within 3 months prior to Screening or use of local glucocorticoid therapies (nasal, topical or inhaled) within 1 month prior to Screening * Use of mineralocorticoid therapies within 3 months prior to Screening * Current use of oral hormonal contraceptives. Extended cycle (e.g., ≥3 month) injectable, or implantable hormonal contraceptives are permissible, provided the cycle will not end during the conduct of the study * Any other condition or prior therapy, that, in the opinion of the Investigator, interferes with the participant's ability to safely complete the study or adhere to study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability as measured by incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) | From Day 1 to approximately day 25 |
| Food Effect (FE) on Pharmacokinetics (PK) of OMS1620 as assessed by maximum concentration (Cmax) in plasma | Two separate assessments (one fasted, one after a high fat meal) of 7 days duration |
| Food Effect (FE) on Pharmacokinetics (PK) of OMS1620 as assessed by area under the plasma concentration versus time curve (AUC) in plasma | Two separate assessments (one fasted, one after a high fat meal) of 7 days duration |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability as measured by incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) | enrollment to approximately Day 25 |
| Pharmacokinetics (PK) of OMS1620 as assessed by maximum concentration (Cmax) in plasma | Day 1 to Day 7 (SAD) or Day 1 to Day 11 (MAD) |
| Pharmacokinetics (PK) of OMS1620 as assessed by area under the plasma concentration versus time curve (AUC) in plasma | Day 1 to Day 7 (SAD) or Day 1 to Day 11 (MAD) |
Outcome results
None listed