A Multiple Ascending Dose Study to Investigate Safety of KBP-7072 in Healthy Subjects

Healthy Clinical Trial

Official title:

A Phase I, Double Blind, Placebo Controlled, Multiple Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of KBP-7072 in Healthy Male and Female Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04532957
• Other study ID #: KBP7072-1-003
• Status: Completed
• Phase: Phase 1
• Start date: August 11, 2020
• Est. completion date: October 15, 2020

Study information

• Verified date: February 2024
• Source: KBP Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a double-blind, placebo-controlled, multiple oral dose study to evaluate safety, tolerability, and pharmacokinetic of KBP-7072 in healthy subjects.

Description:

This was a double-blind, randomized, placebo-controlled, parallel-group, multiple oral dose study. Overall, a total of 24 subjects were studied in 3 groups (Groups 1 to 3); with each group consisting of 8 subjects (6 subjects receiving KBP-7072 and 2 subjects receiving placebo). Groups 1 and 2 evaluated 100 and 200 mg QD, respectively. The dose level of 150 mg QD evaluated in Group 3 was determined based on data obtained from Group 2 of this stud

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 15, 2020
• Est. primary completion date: October 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Females of nonchildbearing potential or males, of any race, between 18 and 50 years of age, inclusive, at screening.

2. Body mass index between 18.0 and 30.0 kg/m2, inclusive, at screening.

3. In good health, determined by no clinically significant findings from medical history, physical and ophthalmologic examinations, 12 lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check in as assessed by the investigator (or designee).

4. Females of nonchildbearing potential defined as permanently sterile or postmenopausal. Males will agree to use contraception.

5. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Exclusion Criteria:

1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).

2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).

3. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed). Cholecystectomy will not be allowed.

4. Alanine aminotransferase or AST = 1 × ULN. Assessments may be repeated once if outside the range at screening and/or check-in, at the discretion of the investigator.

5. Fibroscan controlled attenuation parameter (CAP) > 238 dB/m and vibration controlled transient elastography (VCTE) > 7 kPa.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• KBP-7072
QD oral capsules
• Placebo
matching placebo capsules

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit	Daytona Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
KBP Biosciences	Covance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of KBP-7072 by assessing the number and severity of adverse events, laboratory abnormalities, ECGs, vital signs, and physical examinations.	Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examinations	Day 1 - 10
Secondary	Pharmacokinetics Parameters: Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC0-tlast),	Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC0-tlast) - Plasma	Day 1 predose and at 0.5, 1, 2, 4, 6, 10, 12, 18, and 24 hours postdose; on Days 4, 7, 8 and 9 predose and on Day 10 predose and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours postdose.
Secondary	Pharmacokinetics Parameters: AUC over a dosing interval (AUC0-t), from time zero to time of last quantifiable concentration (AUC0-tlast)	AUC over a dosing interval (AUC0-t) - Plamsa	Day 1 predose and at 0.5, 1, 2, 4, 6, 10, 12, 18, and 24 hours postdose; on Days 4, 7, 8 and 9 predose and on Day 10 predose and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours postdose.
Secondary	Pharmacokinetics Parameters: Maximum observed plasma concentration (Cmax)	Maximum observed plasma concentration (Cmax) - Plasma	Day 1 predose and at 0.5, 1, 2, 4, 6, 10, 12, 18, and 24 hours postdose; on Days 4, 7, 8 and 9 predose and on Day 10 predose and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours postdose.
Secondary	Pharmacokinetics Parameters: time of the maximum observed plasma concentration (Tmax)	Time of the maximum observed plasma concentration (Tmax) - Plasma	Day 1 predose and at 0.5, 1, 2, 4, 6, 10, 12, 18, and 24 hours postdose; on Days 4, 7, 8 and 9 predose and on Day 10 predose and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours postdose.
Secondary	Pharmacokinetics Parameters: apparent terminal elimination half-life (t1/2)	Apparent terminal elimination half-life (t1/2) - Plasma	Day 1 predose and at 0.5, 1, 2, 4, 6, 10, 12, 18, and 24 hours postdose; on Days 4, 7, 8 and 9 predose and on Day 10 predose and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours postdose.
Secondary	Pharmacokinetics Parameters: observed accumulation ratio based on AUC0-t (ARAUC0-t)	Observed accumulation ratio based on AUC0-t (ARAUC0-t) - Plasma	Day 1 predose and at 0.5, 1, 2, 4, 6, 10, 12, 18, and 24 hours postdose; on Days 4, 7, 8 and 9 predose and on Day 10 predose and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours postdose.
Secondary	Pharmacokinetics Parameters: amount of drug excreted in urine (Ae)	Amount of drug excreted in urine (Ae) - Urine	Day 1 at predose (spot collection), 0-6, 6-12, and 12-24 hours postdose, on Days 4, 7, 8 and 9 at predose (spot collection) and on Day 10 at 0-6, 6-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours postdose.