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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
| Imara, Inc. | INDUSTRY |
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The purpose of this Phase 1a, first in human, randomized, double-blind, placebo-controlled study is to evaluate the safety, tolerability, PK and PD profile of the orally administered IMR-687 in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 4 Subjects will receive a single low dose of IMR-687, administered orally following an overnight fast. 2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast. |
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| Cohort 2 | Experimental | 4 Subjects will receive a single low-mid dose of IMR-687, administered orally following an overnight fast. 2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast. |
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| Cohort 3 | Experimental | 4 Subjects will receive a single mid-low dose of IMR-687, administered orally following an overnight fast. 2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast. |
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| Cohort 4 | Experimental | 4 Subjects will receive a single mid dose of IMR-687, administered orally following an overnight fast. 2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast. |
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| Cohort 5 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMR-687 | Drug | 1 of 6 possible single doses administered orally following overnight fast |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment emergent adverse events and serious adverse events | 5 Days | |
| Number of participants with clinically significant changes from baseline in vital signs | Vital signs include blood pressure, heart rate, pulse rate, and oral temperature | Baseline to Day 5 |
| Number of participants with clinically significant changes from baseline in physical examination | Baseline to Day 5 | |
| Number of participants with clinically significant changes from baseline in hematology, chemistry, coagulation and urinalysis laboratory values | Baseline to Day 5 | |
| Number of participants with clinically significant changes from baseline in 12-lead ECG parameters | Baseline to Day 2 | |
| Use of concomitant medications and therapies, medication type and frequency | 5 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of IMR-687 | Maximum Observed Plasma Concentration (Cmax) of IMR-687 | Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose |
| Pharmacokinetics (PK) of IMR-687 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Regulatory Operations | Cardurion Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quintiles | Overland Park | Kansas | 66211 | United States |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D006450 | Hemoglobin SC Disease |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C109691 | microcrystalline cellulose |
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4 Subjects will receive a single mid-high dose of IMR-687, administered orally following an overnight fast. 2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast. |
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| Cohort 6 | Experimental | 4 Subjects will receive a single high dose of IMR-687, administered orally following an overnight fast. 2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast. |
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| Placebo Oral Capsule | Drug | Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient. |
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Area under the curve (AUC) ( 0 to 24 h) of IMR-687
| Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose |
| Pharmacokinetics (PK) of IMR-687 | AUC from time 0 to the last measurable time point (AUClast) of IMR-687 | Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose |
| Pharmacokinetics (PK) of IMR-687 | AUC extrapolated to infinity (AUC0 ∞) of IMR-687 | Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose |
| Pharmacokinetics (PK) of IMR-687 | Time to maximum concentration (tmax) of IMR-687 | Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose |
| Pharmacokinetics (PK) of IMR-687 | Apparent terminal half-life (t½) of IMR-687 | Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose |
| The change from baseline in QTcF interval. | 2 Days |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |