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Trial record 38 of 3084 for:    Area Under Curve AND Healthy

Phase 1 Single Ascending Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of KBP-5074

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ClinicalTrials.gov Identifier: NCT02228733
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
KBP Biosciences

Brief Summary:
This single ascending dose (SAD) study in healthy subjects will evaluate the safety, tolerability and pharmacokinetics of KBP-5074. PK/PD (plasma aldosterone, serum potassium and urine albumin levels) relationships will be explored to support the selection of dosing regimens of KBP-5074 that are suitable for the Phase 2 dose-finding study to evaluate the efficacy, safety and tolerability of KBP-5074 in patients that could slow the progression of nephropathy as well as control hypertension.

Condition or disease Intervention/treatment Phase
Healthy Drug: KBP-5074 Phase 1

Detailed Description:

This is an open-label, parallel-group, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of KBP-5074 following a single dose administration of KBP-5074 with and without food. The study includes 2 parts.

Part 1: Pharmacokinetics from each dose cohort will be characterized before initiation of dosing in the subsequent cohorts. Eight subjects in each dose cohort will receive active drug. The total number of cohorts will be up to 5. Extensive PK samplings will be collected prior to and following administration of single dose of KBP-5074.

Part 2: A separate panel of 6 subjects will receive a single dose of KBP-5074 under fed conditions. Extensive PK samplings will be collected prior to and following administration of single dose of KBP-5074 under fed conditions.

Serum and plasma samples for pharmacodynamic markers (plasma aldosterone and serum potassium levels) will be collected at pre-dose and postdose in both Part 1 and Part 2.

The urine samples will be also used for quantitative determination of urinary albumin in both Part 1 and Part 2.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Parallel-Group, Single Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of KBP-5074 Following Oral Administration and With a Food Effect Panel
Study Start Date : June 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Arm Intervention/treatment
Experimental: KBP-5074: Cohort 1
Healthy Volunteers will receive one dose of KBP-5074
Drug: KBP-5074
Comparisons of different doses of study drug

Experimental: KBP-5074: Cohort 2
Healthy Volunteers will receive one dose of KBP-5074
Drug: KBP-5074
Comparisons of different doses of study drug

Experimental: KBP-5074: Cohort 3
Healthy Volunteers will receive one dose of KBP-5074
Drug: KBP-5074
Comparisons of different doses of study drug

Experimental: KBP-5074: Cohort 4
Healthy Volunteers will receive one dose of KBP-5074
Drug: KBP-5074
Comparisons of different doses of study drug

Experimental: KBP-5074: Cohort 5
Healthy Volunteers will receive one dose of KBP-5074
Drug: KBP-5074
Comparisons of different doses of study drug

Experimental: KBP-5074: Fed Group
Healthy Volunteers will receive one dose of KBP-5074
Drug: KBP-5074
Comparisons of different doses of study drug




Primary Outcome Measures :
  1. The safety and tolerability (i.e., number of participatns with adverse events, abnormal vital signs, clinical laboratory findings, 12-lead ECGs and physical examinations): predose and postdose [ Time Frame: 14 days ]
  2. Area Under Curve (AUC) Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 168, 216, 264 and 312 hours post-dose [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. The effect of food on Area Under Curve (AUC) Time Frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 168, 216, 264 and 312 hours post-dose [ Time Frame: 14 days ]
  2. The plasma aldosterone, serum potassium and urine albumin levels: predose and postdose [ Time Frame: 14 days ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index (BMI) 19 ≤ BMI ≤ 30 kg/m2, no significant medical history, normal renal function and in good general health

Exclusion Criteria:

  • Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity; A history of prescription drug abuse, or illicit drug use within 6 months prior to screening

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Responsible Party: KBP Biosciences
ClinicalTrials.gov Identifier: NCT02228733     History of Changes
Other Study ID Numbers: KBP5074-1-001
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015