Single Ascending Dose (SAD)/Multiple Ascending Dose(MAD) Safety/Pharmacokinetic (PK) Study of KM-023
A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic Characteristics of KM-023 After Oral Administration in Healthy Subjects
1 other identifier
interventional
83
1 country
1
Brief Summary
The purpose of this study is to investigate the safety and pharmacokinetics of KM-023 after single/multiple dosing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 2, 2011
CompletedFirst Posted
Study publicly available on registry
May 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedJuly 26, 2012
July 1, 2012
10 months
May 2, 2011
July 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety/ Tolerability Evaluation
-number of subjects with Adverse events, Physical examinations, Vital signs, electrocardiogram (ECG), Laboratory tests (including hematology, chemistry, coagulation, urinalysis), circulating immune complexes (CIC)
participants will be followed for the duration of hospital stay, 8-10 days for SAD and 14-16 days for MAD
Secondary Outcomes (2)
Pharmacokinetic Evaluation of KM-023, Area under the plasma concentration versus time curve (AUC) of KM-023
participants will be followed for the duration of hospital stay, 8-10 days for SAD and 14-16 days for MAD
Pharmacokinetic Evaluation of KM-023, Peak Plasma Concentration (Cmax) of KM-023
participants will be followed for the duration of hospital stay, 8-10 days for SAD and 14-16 days for MAD
Study Arms (2)
KM-023
EXPERIMENTALPlacebo for KM-023
PLACEBO COMPARATORInterventions
-KM-023 is dosed orally via 75 mg tablets. Study doses are 75 mg, 150 mg, 300 mg, and 600 mg QD for 1 (SAD) or 7 (MAD) days.
-Placebo for KM-023 is dosed orally via Placebo for KM-023 tablets. Study doses are 1, 2, 3, and 4 placebo tablets QD for 1 (SAD) or 7 (MAD) days.
Eligibility Criteria
You may qualify if:
- Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures
- Male or female between 20 and 45 years of age at the time of screening, inclusive
- A subject with body weight ≥ 45 kg and body mass index (BMI) between 18.5 and 25 (inclusive). - BMI (kg/m2) = weight (kg) / {height (m)}2
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
You may not qualify if:
- A subject with a history of allergies to drugs (aspirin, antibiotics, etc.), or history of clinically significant allergies
- A subject with clinical evidence or history of hepatic (including carrier of hepatitis virus), renal, respiratory, endocrine, neurologic, immunologic, hematologic, oncologic, psychiatric, or cardiovascular disease
- A subject with a history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
- A female subject who is pregnant, nursing mother, or sexually active females (childbearing potential)
- Patients who are taking any of the following medications; Bepridil, cisapride, midazolam, pimozide, triazolam, Ergot medications (e.g. Wigraine, cafergot, St. John's wort), Phenobarbitol
- Patients who have previously demonstrated hypersensitivity to Efavirenz or to one of the components of Stocrin or Sustiva
- A positive Hepatitis B surface antigen or positive Hepatitis C antibody at screening.
- A positive test for HIV antibody (as per local practice)
- A subject who has taken any prescribed medication or herbal compounds within 14 days prior to the study drug administration. In addition, a subject who has taken any over-the-counter drug or vitamin supplements within 7 days prior to the study drug administration.
- A subject who has participated in any other clinical trial either for investigational or marketed drugs within 8 weeks before the study drug administration
- A subject who has donated or had loss of ≥ 400 mL of blood within 8 weeks prior to start of administration of study drug
- The value of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is greater than 1.25 times the upper limit of the reference range.
- A subject who is unable to abstain from drinking alcoholic beverages throughout the study period.
- A subject with a history of drug abuse, or a positive urine drug screening test
- A subject who heavily takes caffeine or caffeine-containing products, or takes grapefruit, grapefruit juice, or grapefruit-containing products
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Trials Center, Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2011
First Posted
May 5, 2011
Study Start
May 1, 2011
Primary Completion
March 1, 2012
Last Updated
July 26, 2012
Record last verified: 2012-07