A Multiple Ascending Dose Study to Investigate Safety of KBP-7072 in Healthy Subjects
Study Details
Study Description
Brief Summary
This is a double-blind, placebo-controlled, multiple oral dose study to evaluate safety, tolerability, and pharmacokinetic of KBP-7072 in healthy subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed 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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1 Multiple doses 100mg Healthy subjects receive multiple doses of KBP-7072 (100mg) or Placebo (100mg) QD capsules daily for a total of 10 days |
Drug: KBP-7072
QD oral capsules
Drug: Placebo
matching placebo capsules
|
| Experimental: Group 2 Multiple doses 200mg Healthy subjects receive multiple doses of KBP-7072 (200mg) or Placebo (200mg) QD capsules daily for a total of 10 days |
Drug: KBP-7072
QD oral capsules
Drug: Placebo
matching placebo capsules
|
| Experimental: Group 3 Multiple doses dose tbd Healthy subjects receive multiple doses of KBP-7072 (tbd) or Placebo(tbd) QD capsules daily for a total of 10 days |
Drug: KBP-7072
QD oral capsules
Drug: Placebo
matching placebo capsules
|
Outcome Measures
Primary Outcome Measures
- Safety of KBP-7072 by assessing the number and severity of adverse events, laboratory abnormalities, ECGs, vital signs, and physical examinations. [Day 1 - 10]
Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examinations
Secondary Outcome Measures
- Pharmacokinetics Parameters: Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC0-tlast), [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.]
Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC0-tlast) - Plasma
- Pharmacokinetics Parameters: AUC over a dosing interval (AUC0-τ), from time zero to time of last quantifiable concentration (AUC0-tlast) [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.]
AUC over a dosing interval (AUC0-τ) - Plamsa
- Pharmacokinetics Parameters: Maximum observed plasma concentration (Cmax) [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.]
Maximum observed plasma concentration (Cmax) - Plasma
- Pharmacokinetics Parameters: time of the maximum observed plasma concentration (Tmax) [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.]
Time of the maximum observed plasma concentration (Tmax) - Plasma
- Pharmacokinetics Parameters: apparent terminal elimination half-life (t1/2) [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.]
Apparent terminal elimination half-life (t1/2) - Plasma
- Pharmacokinetics Parameters: observed accumulation ratio based on AUC0-τ (ARAUC0-τ) [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.]
Observed accumulation ratio based on AUC0-τ (ARAUC0-τ) - Plasma
- Pharmacokinetics Parameters: amount of drug excreted in urine (Ae) [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.]
Amount of drug excreted in urine (Ae) - Urine
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Females of nonchildbearing potential or males, of any race, between 18 and 50 years of age, inclusive, at screening.
-
Body mass index between 18.0 and 30.0 kg/m2, inclusive, at screening.
-
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).
-
Females of nonchildbearing potential defined as permanently sterile or postmenopausal. Males will agree to use contraception.
-
Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Exclusion Criteria:
-
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).
-
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
-
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.
-
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.
-
Fibroscan controlled attenuation parameter (CAP) > 238 dB/m and vibration controlled transient elastography (VCTE) > 7 kPa.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Covance Clinical Research Unit | Daytona Beach | Florida | United States | 32117 |
Sponsors and Collaborators
- KBP Biosciences
- Covance
Investigators
- Study Director: James McCabe, MD, KBP Biosciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KBP7072-1-003