Safety, Tolerability and Pharmacokinetics of KBP-7072

Sponsor

KBP Biosciences (Industry)

Overall Status

Completed

CT.gov ID

NCT02454361

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: KBP-7072 Drug: Placebo	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2015

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

The safety and tolerability (i.e., number of participants with adverse events): predose and postdose [10 days]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KBP	Princeton	New Jersey	United States	08540

Sponsors and Collaborators

KBP Biosciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

KBP Biosciences

ClinicalTrials.gov Identifier:

NCT02454361

Other Study ID Numbers:

KBP7072-1-001

First Posted:

May 27, 2015

Last Update Posted:

Dec 29, 2015

Last Verified:

Aug 1, 2015

Keywords provided by KBP Biosciences

Study Results

No Results Posted as of Dec 29, 2015