Study of ISIS 681257 in Patients With Renal Impairment Compared to Healthy Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/26/2018 |
| Start Date: | March 20, 2018 |
| End Date: | January 2019 |
| Contact: | Akcea Therapeutics |
| Email: | clinicalstudies@akceatx.com |
| Phone: | +1 617-207-0297 |
Phase 1, Multicenter, Open-Label, Parallel Group Adaptive Pharmacokinetic Single Dose Study Of ISIS 681257 Subcutaneous Injections In Male And Female Subjects With Normal And Impaired Renal Function
This is a Phase 1, Multicenter, Open-Label, Parallel Group Adaptive Pharmacokinetic Single
Dose Study of ISIS 681257 Subcutaneous Injections in Male And Female Subjects with Normal and
Impaired Renal Function
Dose Study of ISIS 681257 Subcutaneous Injections in Male And Female Subjects with Normal and
Impaired Renal Function
Inclusion Criteria:
- At least 18 years old
- BMI 18.5 to 42.0 kg/m2
- No known diseases or significant findings on physical exam (normal renal only)
- eGFR >/= 90 mL/min/1.73m2 (normal renal only)
- Clinically stable (renal impaired only)
- eGFR 30-59 mL/min/1.73m2 (renal impaired only)
Exclusion Criteria:
- Females of childbearing potential
- Conditions or disease that may interfere with study drug
- Any significant diseases
- Hypersensitivity to any drugs or similar drugs to those used in the study
- Drug dependency or abuse
- Previous exposure to other investigational drug within 28 days
- Blood donations within 28 days
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