HealthyPhase 1NCT06644326
A PK Study of IkT-148009 in Older and Elderly Healthy Subjects
A Phase 1 study testing 100mg IkT-148009 Wet, 200 mg Itraconazole and 100mg IkT-148009 Dry in people with Healthy, run by ABLi Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a two-part study. Part A consists of two different IkT-148009-201 solid dosage formulations that are being evaluated to determine their steady-state pharmacokinetic profile. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 100mg IkT-148009 Wet, 200 mg Itraconazole and 100mg IkT-148009 Dry
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2023to 27 Aug 2024
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject must have all questions about the study answered and must have signed the informed consent document before any study-specific procedures are performed.
- Healthy ambulatory male and female subjects with no history or evidence of clinically relevant medical disorders as determined by the Investigator in consultation with the Sponsor.
- Bodyweight > 50 kg and body mass index (BMI) > 18.0 and < 32.0 kg/m2.
- Physical examination, clinical laboratory values, vital signs, and electrocardiogram (ECG) data.
- Female subjects must be postmenopausal, permanently sterile (bilateral tubal occlusion), or of childbearing potential with a negative pregnancy test, non-breastfeeding, and using two highly effective methods of birth control.
- Male subjects must agree to practice an acceptable method of highly effective birth control.
- Males must be willing to abstain from sperm donation from the screening visit, while on study and through 30 days after receiving the last dose of study drug.
Who cannot join
- Any subject with previous exposure to imatinib or known hypersensitivity to imatinib.
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at the screening and admission visits.
- Clinically significant abnormal physical examination or 12-lead electrocardiogram (ECG) at the screening or admission visits.
- Clinically significant abnormal renal function.
- Significant history (within six months prior to receiving the study drug) and/or presence of hepatic, renal, cardiovascular, pulmonary, gastrointestinal, endocrinological, hematological, dermatological, psychiatric, neurological, immunologic, ophthalmologic, metabolic, fluid retention and edema, bleeding disorders including hemorrhage or oncological disease.
- Any subject with a history, presence and/or current evidence of serologic positive result for hepatitis B surface antigen, hepatitis C antibodies, or HIV antibodies 1 or 2.
Show all 14Show fewer
- Recent history (within previous six months prior to screening) of alcohol or drug abuse (as judged by the investigator), or has consumed > 2 alcohol drinks/day during the last three months prior to screening.
- Any subject who currently uses or has regularly used tobacco or tobacco-containing products (cigarettes, pipes, etc.) for at least 30 days prior to screening or positive urine cotinine screen at the screening or admission visits.
- Any subject who has received treatment with an investigational drug during the 30 days prior to screening. Exposure to an investigational medical device within 30 days of screening.
- Use of agents known to affect drug metabolism: use of any known CYP3A4 inducers and/or inhibitors or consumed grapefruit juice, grapefruit, Seville oranges or St John's Wort or products containing these within 14 days prior to first administration of study drug. Strong inducers of CYP3A4 include dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifampicin and phenobarbital. Strong inhibitors of CYP3A4 include ketoconazole, itroconazole, clarythromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole.
- Investigative site personnel or their immediate families (spouse, parent, child or sibling whether biological or legally adopted).
- Any subject unwilling or unable to comply with study procedures.
- Pregnant or nursing women.
- Anyone who does not meet the requirements for exclusion of certain concomitant medications as defined in Section 7.5.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmacokinetic Bridging Study of Film-Coated Tablets of IkT-148009 in Older and Elderly Healthy Subjects
This is a two-part study. Part A consists of two different IkT-148009-201 solid dosage formulations that are being evaluated to determine their steady-state pharmacokinetic profile.
Part B is a drug-drug interaction (DDI) study focused on evaluating the impact of a strong CYP3A inhibitor on the preferred dosage determined in part A.
Read the detailed description
This is a two-part study.
Part A is a single dose (7-day) study to determine the safety, tolerability and pharmacokinetics (PK) of two different tablet formulations of IkT-148009 in older and elderly healthy subjects.
Subjects in each cohort of the study will be admitted to the unit the day prior to the expected day of dosing and will be confined to the unit for approximately 12 days. Each cohort will consist of six (6) subjects who will receive treatment with one of two formulations of IkT- 148009 film-coated tablets at a single dose once daily for 7 days.
Part B is a Drug-Drug Interaction (DDI) study to determine the effect of itraconazole on the pharmacokinetics of IkT-148009.
Subjects in each cohort of the study will be admitted to the unit the day prior to the expected day of dosing in each period and will be confined to the unit for approximately 6 days in period 1 and 10 days in period 2. Up to eight (8) subjects will be evaluated in a two-period design in the fed state.
In Period 1, the 50 mg film-coated IkT-148009 tablet dose pharmacokinetics will be measured, followed by a 7-day washout. In Period 2, the same eight subjects will first be administered a 200 mg once daily capsule dose of itraconazole for four days. On Period 2 day 4 subjects will take a single 200 mg capsule dose of itraconazole, followed one hour later by a 50 mg film-coated tablet dose of IkT-148009.
- Conditions
- Healthy
- Being tested
- 100mg IkT-148009 Wet, 200 mg Itraconazole, 100mg IkT-148009 Dry, 50mg IkT-148009 Wet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100mg IkT-148009 WetDrug
100mg wet tablet formulation
200 mg ItraconazoleDrug
2 100mg capsules
100mg IkT-148009 DryDrug
100mg dry tablet formulation
50mg IkT-148009 WetDrug
50mg wet tablet formulation
| Study group | Role | What they receive |
|---|---|---|
| Part A IkT-148009 Dry/Wet | Active comparator | 100mg IkT-148009 Wet \& 100mg IkT-148009 Dry Receives: Drug: 100mg IkT-148009 Wet; Drug: 100mg IkT-148009 Dry |
| Part B - Ikt-148009 wet/ Itraconazole | Active comparator | 200 mg Itraconazole \& 50mg IkT-148009 Wet Receives: Drug: 200 mg Itraconazole; Drug: 50mg IkT-148009 Wet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Safety
Changes in vital sign measurements including HR and blood pressure.
Measured: Through study completion, an average of 17 days
Patient Safety
Changes in clinical laboratory data consisting of CBC, Serum Chemistry, FSH
Measured: Through study completion, an average of 17 days
Patient Safety
Electrocardiogram [ECG] parameters of ventricular rate, RR or PR interval, QRS complex, and QTcF interval.
Measured: Through study completion, an average of 17 days
Patient Safety
C-SSRS assessment values.
Measured: Through study completion, an average of 17 days
Pharmacokinetic parameters in the absence or presence of itraconazole:
Pharmacokinetic parameters:
- Area under the concentration-time curve from time zero to 96 hours (AUC0-∞)
Measured: Through study completion, an average of 17 days
Pharmacokinetic parameters in the absence or presence of itraconazole:
Pharmacokinetic parameters:
- Maximum plasma concentration (Cmax)
Measured: Through study completion, an average of 17 days
Pharmacokinetic parameters in the absence or presence of itraconazole:
Pharmacokinetic parameters:
- Area under the concentration-time curve from time zero to last time point (AUC0-last)
Measured: Through study completion, an average of 17 days
Assess the pharmacokinetics (PK) of IkT-148009
Pharmacokinetic parameters:
- Area under the concentration-time curve from time zero to 96 hours (AUC0-∞)
Measured: Through study completion, an average of 17 days
Assess the pharmacokinetics (PK) of IkT-148009
Pharmacokinetic parameters:
- Maximum plasma concentration (Cmax)
Measured: Through study completion, an average of 17 days
Assess the pharmacokinetics (PK) of IkT-148009
Pharmacokinetic parameters:
- Area under the concentration-time curve from time zero to last time point (AUC0-last)
Measured: Through study completion, an average of 17 days
Patient Tolerability
Adverse event reporting
Measured: Through study completion, an average of 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start21 Jun 2023
- Primary completion17 Aug 2024
- Study completion27 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- ABLi Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644326
- Sponsor's protocol ID
- IkT-148009-103
- Status last verified
- Oct 2024
- First submitted
- 12 Sep 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Bridging Study of Film-Coated Tablets of IkT-148009 in Older and Elderly Healthy Subjects
- ClinicalTrials.gov ID
- NCT06644326
- Acronym / sponsor ID
- IkT-148009-103
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- ABLi Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 17 Aug 2024 (actual)
- Study completion
- 27 Aug 2024 (actual)
- First posted
- 16 Oct 2024 (actual)
- 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.
This is a two-part study. Part A consists of two different IkT-148009-201 solid dosage formulations that are being evaluated to determine their steady-state pharmacokinetic profile.
Part B is a drug-drug interaction (DDI) study focused on evaluating the impact of a strong CYP3A inhibitor on the preferred dosage determined in part A.
Detailed description
This is a two-part study.
Part A is a single dose (7-day) study to determine the safety, tolerability and pharmacokinetics (PK) of two different tablet formulations of IkT-148009 in older and elderly healthy subjects.
Subjects in each cohort of the study will be admitted to the unit the day prior to the expected day of dosing and will be confined to the unit for approximately 12 days. Each cohort will consist of six (6) subjects who will receive treatment with one of two formulations of IkT- 148009 film-coated tablets at a single dose once daily for 7 days.
Part B is a Drug-Drug Interaction (DDI) study to determine the effect of itraconazole on the pharmacokinetics of IkT-148009.
Subjects in each cohort of the study will be admitted to the unit the day prior to the expected day of dosing in each period and will be confined to the unit for approximately 6 days in period 1 and 10 days in period 2. Up to eight (8) subjects will be evaluated in a two-period design in the fed state.
In Period 1, the 50 mg film-coated IkT-148009 tablet dose pharmacokinetics will be measured, followed by a 7-day washout. In Period 2, the same eight subjects will first be administered a 200 mg once daily capsule dose of itraconazole for four days. On Period 2 day 4 subjects will take a single 200 mg capsule dose of itraconazole, followed one hour later by a 50 mg film-coated tablet dose of IkT-148009.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A IkT-148009 Dry/Wet | Active comparator | Drug: 100mg IkT-148009 Wet, Drug: 100mg IkT-148009 Dry100mg IkT-148009 Wet \& 100mg IkT-148009 Dry |
| Part B - Ikt-148009 wet/ Itraconazole | Active comparator | Drug: 200 mg Itraconazole, Drug: 50mg IkT-148009 Wet200 mg Itraconazole \& 50mg IkT-148009 Wet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject must have all questions about the study answered and must have signed the informed consent document before any study-specific procedures are performed.
- Healthy ambulatory male and female subjects with no history or evidence of clinically relevant medical disorders as determined by the Investigator in consultation with the Sponsor.
- Bodyweight > 50 kg and body mass index (BMI) > 18.0 and < 32.0 kg/m2.
- Physical examination, clinical laboratory values, vital signs, and electrocardiogram (ECG) data.
- Female subjects must be postmenopausal, permanently sterile (bilateral tubal occlusion), or of childbearing potential with a negative pregnancy test, non-breastfeeding, and using two highly effective methods of birth control.
Key exclusion criteria (14 listed)
- Any subject with previous exposure to imatinib or known hypersensitivity to imatinib.
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at the screening and admission visits.
- Clinically significant abnormal physical examination or 12-lead electrocardiogram (ECG) at the screening or admission visits.
- Clinically significant abnormal renal function.
- Significant history (within six months prior to receiving the study drug) and/or presence of hepatic, renal, cardiovascular, pulmonary, gastrointestinal, endocrinological, hematological, dermatological, psychiatric, neurological, immunologic, ophthalmologic, metabolic, fluid retention and edema, bleeding disorders including hemorrhage or oncological disease.
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 |
|---|---|---|
| 100mg IkT-148009 Wet100mg wet tablet formulation | Drug | Part A IkT-148009 Dry/Wet |
| 200 mg Itraconazole2 100mg capsules | Drug | Part B - Ikt-148009 wet/ Itraconazole |
| 100mg IkT-148009 Dry100mg dry tablet formulation | Drug | Part A IkT-148009 Dry/Wet |
| 50mg IkT-148009 Wet50mg wet tablet formulation | Drug | Part B - Ikt-148009 wet/ Itraconazole |
Primary outcome
Patient Safety
Time frame: Through study completion, an average of 17 days
Changes in vital sign measurements including HR and blood pressure.
Patient Safety
Time frame: Through study completion, an average of 17 days
Changes in clinical laboratory data consisting of CBC, Serum Chemistry, FSH
Patient Safety
Time frame: Through study completion, an average of 17 days
Electrocardiogram [ECG] parameters of ventricular rate, RR or PR interval, QRS complex, and QTcF interval.
Patient Safety
Time frame: Through study completion, an average of 17 days
C-SSRS assessment values.
Pharmacokinetic parameters in the absence or presence of itraconazole:
Time frame: Through study completion, an average of 17 days
Pharmacokinetic parameters: • Area under the concentration-time curve from time zero to 96 hours (AUC0-∞)
Pharmacokinetic parameters in the absence or presence of itraconazole:
Time frame: Through study completion, an average of 17 days
Pharmacokinetic parameters: • Maximum plasma concentration (Cmax)
Pharmacokinetic parameters in the absence or presence of itraconazole:
Time frame: Through study completion, an average of 17 days
Pharmacokinetic parameters: • Area under the concentration-time curve from time zero to last time point (AUC0-last)
Assess the pharmacokinetics (PK) of IkT-148009
Time frame: Through study completion, an average of 17 days
Pharmacokinetic parameters: • Area under the concentration-time curve from time zero to 96 hours (AUC0-∞)
Assess the pharmacokinetics (PK) of IkT-148009
Time frame: Through study completion, an average of 17 days
Pharmacokinetic parameters: • Maximum plasma concentration (Cmax)
Assess the pharmacokinetics (PK) of IkT-148009
Time frame: Through study completion, an average of 17 days
Pharmacokinetic parameters: • Area under the concentration-time curve from time zero to last time point (AUC0-last)
Patient Tolerability
Time frame: Through study completion, an average of 17 days
Adverse event reporting
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 16 Oct 2024.
- Individual participant dataSharing planned: No
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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 100mg IkT-148009 Wet, 200 mg Itraconazole and 100mg IkT-148009 Dry in people with Healthy, run by ABLi Therapeutics, Inc. at 1 site in United States.
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 7 inclusion and 14 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 16 Oct 2024. 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 United States. 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. 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?
Patient Safety (time frame: Through study completion, an average of 17 days). The study lists 11 primary outcomes in all. 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 16 Oct 2024.