Safety, Tolerability and Pharmacokinetics of KBP-7072

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02454361

Enrollment

Registered

2015-05-27

Start date

2015-05-31

Completion date

2015-12-31

Last updated

2024-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Safety, tolerability, pharmacokinetics, KBP-7072

Brief summary

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.

Interventions

DRUGKBP-7072

KBP-7072

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026