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Single Center, Randomized, Double Blind, Placebo Controlled, Single ascending dose trial at 3 levels. Ten subjects will be enrolled at each dose.
This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose trial with single oral doses of HTI-2088 tablets to subjects at 3 levels (2.5, 3.75, 5 mg). Ten subjects will be enrolled at each dose level, randomized within groups at an active: placebo ratio of 4:1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Experimental | 2mg, HTI-2088 oral tablet or placebo, one dose, evaluate over 4 days |
|
| Middle Dose | Experimental | 3.75mg HTI-2088 oral tablet or placebo, one dose, evaluate over 4 days |
|
| High Dose | Experimental | 5mg HTI-2088 oral tablet or placebo, one dose, evaluate over 4 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HTI-2088 | Drug | 3 dose levels |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 1 week |
| Cmax | Peak Plasma Concentration (Cmax) | 1 week |
| AUC | Area under the plasma concentration versus time curve (AUC) | 1 Week |
| Measure | Description | Time Frame |
|---|---|---|
| PD Effects | effects on Glucose, Insulin, Insulin C-peptide | 1 week |
| Glucose | Number of patients with effects on Glucose, Insulin, Insulin C-peptide |
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Inclusion Criteria:
Healthy male or female between 18 and 55 years of age (inclusive), without diabetes FPG <126 mg/dL.
Body mass index (BMI) of 19 to 30 kg/m2 (inclusive); and a total body weight ≥50 kg.
Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
An informed consent document signed and dated by the subject.
Male subjects must agree to utilize a highly effective method of contraception (condom with or without spermicide) during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from first dose throughout the study period and for 90 days following IP dosing, and must agree to refrain from sperm donation from Day 0 until at least 90 days after the IP dose.
Females must meet at least one of the following criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medpace | Cincinnati | Ohio | 45227 | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Placebo |
| Drug |
placebo oral tablet |
|
| 1 week |
| Insulin | Number of patients with effects on Insulin and Insulin C-peptide | 1 week |