Human Immunodeficiency VirusPhase 1NCT01348516
Single Ascending Dose (SAD)/Multiple Ascending Dose(MAD) Safety/Pharmacokinetic (PK) Study of KM-023
A Phase 1 study testing KM-023 in people with Human Immunodeficiency Virus, run by Kainos Medicine Inc. at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the safety and pharmacokinetics of KM-023 after single/multiple dosing. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- KM-023
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Mar 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
- A subject who is unable to eat a standardized meal offered by the study center
- A subject who will be previously assigned to treatment during this study (except those who did not take any study medications)
- 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.
- The investigator judges the subject not eligible for the study after reviewing clinical laboratory results or other reasons
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trials Center, Seoul National University Hospital
Seoul
About this study
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
The purpose of this study is to investigate the safety and pharmacokinetics of KM-023 after single/multiple dosing.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- KM-023, Placebo for KM-023
- Keywords
- HIV
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KM-023Drug
-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-023Drug
-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.
| Study group | Role | What they receive |
|---|---|---|
| KM-023 | Experimental | Not described Receives: Drug: KM-023 |
| Placebo for KM-023 | Placebo comparator | Not described Receives: Drug: Placebo for KM-023 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
-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
Measured: 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
-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
Measured: participants will be followed for the duration of hospital stay, 8-10 days for SAD and 14-16 days for MAD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startMay 2011
- Primary completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kainos Medicine Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348516
- Sponsor's protocol ID
- KMCP-023-101
- Status last verified
- Jul 2012
- First submitted
- 2 May 2011
- Last updated
- 26 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01348516
- Acronym / sponsor ID
- KMCP-023-101
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Kainos Medicine Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Mar 2012 (actual)
- First posted
- 5 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the safety and pharmacokinetics of KM-023 after single/multiple dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KM-023 | Experimental | Drug: KM-023 |
| Placebo for KM-023 | Placebo comparator | Drug: Placebo for KM-023 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | KM-023 |
| 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. | Drug | Placebo for KM-023 |
Primary outcome
Safety/ Tolerability Evaluation
Time frame: participants will be followed for the duration of hospital stay, 8-10 days for SAD and 14-16 days for MAD
-number of subjects with Adverse events, Physical examinations, Vital signs, electrocardiogram (ECG), Laboratory tests (including hematology, chemistry, coagulation, urinalysis), circulating immune complexes (CIC)
2 secondary outcomes
Pharmacokinetic Evaluation of KM-023, Area under the plasma concentration versus time curve (AUC) of KM-023
Time frame: 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
Time frame: participants will be followed for the duration of hospital stay, 8-10 days for SAD and 14-16 days for MAD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KM-023 in people with Human Immunodeficiency Virus, run by Kainos Medicine Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety/ Tolerability Evaluation (time frame: participants will be followed for the duration of hospital stay, 8-10 days for SAD and 14-16 days for MAD). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2012.