Effects of Ferrous Sulfate on the Pharmacokinetics of AKB-6548
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 11/16/2018 |
| Start Date: | December 2014 |
| End Date: | February 2015 |
An Open-Label, Randomized, Single-Dose Study to Evaluate the Effects of 325 mg Ferrous Sulfate Tablet (65 mg Iron) on the Pharmacokinetics of 450 mg Dose of AKB-6548 in Healthy Male Volunteers.
The primary purpose of this study is to assess the single-dose bioavailability of AKB-6548
with ferrous sulfate relative to AKB-6548 in healthy volunteers.
with ferrous sulfate relative to AKB-6548 in healthy volunteers.
Inclusion Criteria:
- Healthy male subjects 18 to 55 years of age with a body mass index between 18 and 30
kg/m2
- Participants and their partners must use a highly effective form of contraception
during the study and for 1 month following discharge from the Clinical Research Unit
(CRU)
- Subjects must discontinue all iron preparations for 14 days prior to study drug
administration
Exclusion Criteria:
- Current or past history of cardiovascular, cerebrovascular, pulmonary, renal or liver
disease
- Positive serology results for HBsAg, HCV, and HIV at Screening
- Renal impairment (estimated glomerular filtration rate (eGFR) of <65mL/min)
- Known active cancer (except non-melanoma skin cancer) or history of chemotherapy use
within the previous 24 months
- Current or past history of gastric or duodenal ulcers or other diseases of the GI
tract (including gastric bypass surgeries) that could interfere with absorption of
study drug
- Subjects with a known history of smoking and/or have used nicotine or
nicotine-containing products within the past 6 months
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