Safety, Tolerability and Pharmacokinetics of KBP-7072

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of KBP-7072 Following Oral Administration

Conditions
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Healthy

Intervention / Treatment
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* Drug: KBP-7072
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, pulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KBP-7072 cohort 1<br>KBP-7072 by mouth once | Drug: KBP-7072<br>* KBP-7072<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: KBP-7072 cohort 2<br>KBP-7072 by mouth once | Drug: KBP-7072<br>* KBP-7072<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: KBP-7072 cohort 3<br>KBP-7072 by mouth once | Drug: KBP-7072<br>* KBP-7072<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: KBP-7072 cohort 4<br>KBP-7072 by mouth once | Drug: KBP-7072<br>* KBP-7072<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: KBP-7072 cohort 5<br>KBP-7072 by mouth once | Drug: KBP-7072<br>* KBP-7072<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: KBP-7072 Fed Group<br>KBP-7072 by mouth once to the fed group | Drug: KBP-7072<br>* KBP-7072<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety and tolerability (i.e., number of participants with adverse events): predose and postdose |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, tolerability, pharmacokinetics, KBP-7072