Safety, Tolerability and Pharmacokinetics of KBP-7072
- Registration Number
- NCT02454361
- Lead Sponsor
- KBP Biosciences
- Brief Summary
This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of a single dose of KBP-7072 following oral single ascending dose administration and with an open label food effect panel.
- Detailed Description
This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of a single dose of KBP-7072 following oral single ascending dose administration and with an open label food effect panel.
Part 1: A total of 40 subjects will be evaluated with 30 subjects randomized to receive active drug and 10 subjects randomized to receive placebo in a double-blind fashion (eight subjects in each dose cohort, six subjects randomized to active drug and two subjects randomized to placebo). 5 dose levels will be evaluated. Extensive PK samplings will be collected after dosing (pre-dose (within 30 min prior to dosing) and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hr post-dose).
Part 2: A separate panel of 6 subjects will receive a single dose of KBP-7072 under fed conditions. The dose tested in Part 2 will be determined based on the safety, tolerability and PK data available from Part 1. Extensive PK samplings will be collected after dosing (pre-dose (within 45 min prior to dosing) and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hr post-dose).
Safety assessments will include monitoring of adverse events (AEs), vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings, 12-lead electrocardiograms (ECGs), and physical examination findings.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- males and surgically sterile or postmenopausal females
- aged between 18-45 years
- body mass index (BMI) 19 ≤ BMI ≤ 30 kg/m2,
- no significant medical history
- normal renal function
- good general health
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, pulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KBP-7072 cohort 4 KBP-7072 KBP-7072 by mouth once KBP-7072 cohort 5 Placebo KBP-7072 by mouth once KBP-7072 cohort 1 Placebo KBP-7072 by mouth once KBP-7072 cohort 3 KBP-7072 KBP-7072 by mouth once KBP-7072 cohort 2 KBP-7072 KBP-7072 by mouth once KBP-7072 cohort 2 Placebo KBP-7072 by mouth once KBP-7072 cohort 3 Placebo KBP-7072 by mouth once KBP-7072 cohort 4 Placebo KBP-7072 by mouth once KBP-7072 cohort 1 KBP-7072 KBP-7072 by mouth once KBP-7072 Fed Group KBP-7072 KBP-7072 by mouth once to the fed group KBP-7072 cohort 5 KBP-7072 KBP-7072 by mouth once
- Primary Outcome Measures
Name Time Method The safety and tolerability (i.e., number of participants with adverse events): predose and postdose 10 days
- Secondary Outcome Measures
Name Time Method Area Under Curve (AUC) Time Frame: predose, 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hr post-dose 10 days Area Under Curve (AUC) Time Frame: predose, 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hr post-dose among participants who have had food 10 days
Trial Locations
- Locations (1)
KBP
🇺🇸Princeton, New Jersey, United States