Single Ascending Dose (SAD)/Multiple Ascending Dose(MAD) Safety/Pharmacokinetic (PK) Study of KM-023

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348516
• Other study ID #: KMCP-023-101
• Status: Completed
• Phase: Phase 1
• First received: May 2, 2011
• Last updated: July 24, 2012
• Start date: May 2011

Study information

• Verified date: July 2012
• Source: Kainos Medicine Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the safety and pharmacokinetics of KM-023 after single/multiple dosing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

1. A subject with a history of allergies to drugs (aspirin, antibiotics, etc.), or history of clinically significant allergies

2. 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

3. 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

4. A female subject who is pregnant, nursing mother, or sexually active females (childbearing potential)

5. 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

6. Patients who have previously demonstrated hypersensitivity to Efavirenz or to one of the components of Stocrin or Sustiva

7. A positive Hepatitis B surface antigen or positive Hepatitis C antibody at screening.

8. A positive test for HIV antibody (as per local practice)

9. 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.

10. A subject who has participated in any other clinical trial either for investigational or marketed drugs within 8 weeks before the study drug administration

11. A subject who has donated or had loss of = 400 mL of blood within 8 weeks prior to start of administration of study drug

12. The value of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is greater than 1.25 times the upper limit of the reference range.

13. A subject who is unable to abstain from drinking alcoholic beverages throughout the study period.

14. A subject with a history of drug abuse, or a positive urine drug screening test

15. A subject who heavily takes caffeine or caffeine-containing products, or takes grapefruit, grapefruit juice, or grapefruit-containing products

16. A subject who is unable to eat a standardized meal offered by the study center

17. A subject who will be previously assigned to treatment during this study (except those who did not take any study medications)

18. Systolic blood pressure outside the range of 80 to 140 mm Hg, or diastolic blood pressure outside the range of 60 to 85 mm Hg, or heart rate outside the range of 50 to 100 beats per minute (bpm) for females; outside and the range of 45 to 100 beats per minute (bpm) for male subjects. Blood pressure and heart rate should be taken after 10 minutes of rest.

19. The investigator judges the subject not eligible for the study after reviewing clinical laboratory results or other reasons

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Drug:
• KM-023
-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
-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.

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trials Center, Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kainos Medicine Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Pharmacokinetic Evaluation of KM-023, Area under the plasma concentration versus time curve (AUC) of KM-023	-Serial blood samples and urine collections for pharmacokinetic evaluations will be conducted pre-dose through post dose in order to evaluate 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	No
Secondary	Pharmacokinetic Evaluation of KM-023, Peak Plasma Concentration (Cmax) of KM-023	-Serial blood samples and urine collections for pharmacokinetic evaluations will be conducted pre-dose through post dose in order to evaluate 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	No