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The purpose of this study is to assess the safety, tolerability, pharmacokinetics, food effect, and pharmacodynamics following a single oral dose of IA-14069 in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A mg IA-14069 or Placebo | Experimental |
| |
| B mg IA-14069 or Placebo | Experimental |
| |
| C mg IA-14069 or Placebo | Experimental | Period 1: Fasted condition → Period 2: Fed condition |
|
| D mg IA-14069 or Placebo | Experimental |
| |
| E mg IA-14069 or Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IA-14069 | Drug | Subjects received IA-14069 tablet orally on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | Up to Day 14 | |
| Incidence and severity of clinical findings on physical examination | Up to Day 8 | |
| Change from baseline in vital signs: Blood pressure (Systolic/Diastolic) | Up to Day 8 | |
| Change from baseline in vital signs: Body temperature | Up to Day 8 | |
| Change from baseline in vital signs: Respiratory rate | Up to Day 8 | |
| Change from baseline in vital signs: Heart rate | Up to Day 8 | |
| Incidence and severity of clinical laboratory abnormalities | Hematology, serum chemistry and urinalysis | Up to Day 8 |
| Change from baseline in 12-lead ECG parameters | PR, QRS, QT and QTc intervals | Up to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) for IA-14069 | Up to Day 8 | |
| Time to maximum concentration (Tmax) for IA-14069 | Up to Day 8 | |
| Area under the concentration-time curve (AUC) for IA-14069 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in concentration of Tumor necrosis factor in blood | Up to Day 8 |
Inclusion Criteria:
Signed the ICF.
Male subjects, ≥ 18 to ≤ 55 years of age at the time of signing the ICF.
Overtly healthy as determined by medical evaluation including medical history, physical examination and clinical laboratory tests.
Body mass index (BMI) within ≥ 18.0 to ≤ 32.0 kg/m2 and body weight not less than 50 kg.
Pulse rate between 40 and 100 beats per minutes (bpm)
A 12-lead ECG consistent with normal cardiac conduction and function, including:
Non-smoker or ex-smoker for > 6 months.
Agree to use contraception (Appendix 1) during the treatment period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON plc. | Lenexa | Kansas | 66219 | United States |
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| Placebo | Drug | Subjects received matching placebo tablet orally on Day 1. |
|
| Up to Day 8 |
| Terminal elimination half-life (t1/2) for IA-14069 | Up to Day 8 |
| Apparent clearance (CL/F) for IA-14069 | Up to Day 8 |
| Apparent volume of distribution (Vd/F) for IA-14069 | Up to Day 8 |
| Pharmacokinetic (PK) in Food effect measured by Cmax for IA-14069 | Up to Day 8 |
| PK in Food effect measured by Tmax for IA-14069 | Up to Day 8 |
| PK in Food effect measured by AUC for IA-14069 | Up to Day 8 |
| PK in Food effect measured by t1/2 for IA-14069 | Up to Day 8 |