Tuberculosis InfectionPhase 1PRiMeNCT07069582
Pharmacokinetics of Antituberculosis Drugs in Breastfeeding Women
A Phase 1 study testing Standard dose rifampicin, High dose rifampicin and Standard dose isoniazid in people with Tuberculosis Infection and Healthy Volunteer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Indonesia.
Trial summary
This study is a sub-study of the SSTARLET trial (NCT06498414). The overall aim is to assess the pharmacokinetic profiles after taking a single dose of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline in breastfeeding women and the excretion of these drugs in breast milk, with the hope of including… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis Infection, Healthy Volunteer, Breastfeeding
- What is being tested?
- Standard dose rifampicin, High dose rifampicin and Standard dose isoniazid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2026to 31 Oct 2026
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants may enter the study if all of the following apply:
- Healthy breastfeeding women aged 18 years or older, with a minimum of 3 months and a maximum of 24 months after delivery of a healthy baby, and are not currently diagnosed with either TB infection or TB disease.
- Have a body weight between 25 and 100 kg.
- Provide written informed consent.
Who cannot join
- Participants may not enter the study if any of the following criteria apply:
- Grade 3-4 abnormalities on baseline blood chemistry tests, including serum alanine aminotransferase (ALT), creatinine, or blood glucose.
- Grade 3-4 abnormalities on baseline hematological tests, including white blood count, platelets, or hemoglobin.
- Contraindications or history of hypersensitivity/intolerance to rifampicin, isoniazid, levofloxacin, rifapentine, or bedaquiline.
- Taking concomitant medications for TB disease, TB infection, diabetes mellitus, hypertension, HIV, cardiac disease or any other chronic diseases.
- Having a breastfed infant who was diagnosed with TB infection or TB disease and is currently on treatment.
- Pregnancy
- Have an active, acute illness at the time of study enrolment.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Universitas Padjadjaran, Klinik Penelitian Tuberculosis (TB Research Clinic)
Bandung, West Java, 40161
About this study
Official title: Plasma and Breastmilk Exposures to Antituberculosis Drugs in Breastfeeding Women: an Open-label, Randomized, Six-arm, Single-dose, Pharmacokinetic Study
This study is a sub-study of the SSTARLET trial (NCT06498414). The overall aim is to assess the pharmacokinetic profiles after taking a single dose of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline in breastfeeding women and the excretion of these drugs in breast milk, with the hope of including breastfeeding women in future clinical trials of TPT, including expanding the inclusion criteria of the SSTARLET trial. In this study, healthy breastfeeding women who fulfill the eligibility criteria will be enrolled from several primary health care centers in Bandung, which will be referred to the TB Research Clinic of the Universitas Padjadjaran, Bandung, Indonesia. Ten participants will be randomized to each of the following six study arms:
- Arm A: Single-dose rifampicin at 10 mg/kg body weight (RIF10).
- Arm B: Single-dose rifampicin at 20 mg/kg body weight (RIF20).
- Arm C: Single-dose isoniazid at 5 mg/kg body weight (INH5).
- Arm D: Single-dose levofloxacin at 10-15 mg/kg body weight (LFX10-15).
- Arm E: Single-dose rifapentine at 10 mg/kg body weight (RPT10).
- Arm F: Single-dose bedaquiline at 400 mg (BDQ400).
Read the detailed description
Pregnant and breastfeeding women have been largely excluded from recent and ongoing clinical trials due to ethical concerns, limiting their access to the latest advancements in tuberculosis (TB) therapy. To support the development of short, effective tuberculosis preventive treatment (TPT) regimens lasting 1-2 months, a phase 2 adaptive clinical trial (SSTARLET trial) is being planned. This trial will evaluate three experimental regimens: two months of daily double-dose rifampicin; one month of daily levofloxacin and rifapentine; and either one month of daily isoniazid and rifapentine or a bedaquiline-containing regimen. The comparator will be the current standard of four months of daily rifampicin. The safest and shortest regimen will be selected for progression to a phase 3 trial. Inclusion of breastfeeding women in future trials of these regimens is intended; however, limited pharmacokinetic (PK) and safety data exist regarding the excretion of these drugs into breast milk, which is necessary to support their use in this population.
The current study aims to establish the PK profiles of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline in breastfeeding women and the excretion of these drugs in breast milk, with the hope of including breastfeeding women in future clinical trials of TPT. The specific objective of the study is to describe the PK profiles after a single dose of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline in plasma and breast milk of breastfeeding women.
In this study, healthy breastfeeding women who fulfill the eligibility criteria will be enrolled from several primary health care centers in Bandung, which will be referred to the TB Research Clinic of the Universitas Padjadjaran, Bandung, Indonesia.
The primary outcomes in this study are the total drug exposure, i.e., the area under the concentration-time curve from 0 to 24 hours after drug administration (AUC0-24) and peak concentration (Cmax) of single doses of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline in plasma and breastmilk of breastfeeding women, including the breast milk/plasma ratios for AUC0-24 and Cmax to estimate the external exposure of the drugs to breastfed infants. The secondary outcomes are PK measures of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline other than AUC0-24 and Cmax, including time to Cmax (Tmax), elimination rate constant (Ke), elimination half-life (t1/2), apparent clearance (CL/F), and apparent volume of distribution (Vd/F) in plasma and breast milk of breastfeeding women.
The study design is an open-label, randomized, six-arm, single-dose, intensive PK study, that will be performed at the TB Research Clinic of the Universitas Padjadjaran, Bandung, Indonesia. Six oral drug dosages will be evaluated: rifampicin 10 mg/kg (RIF10), rifampicin 20 mg/kg (RIF20), levofloxacin 10-15 mg/kg (LFX10-15), rifapentine 10 mg/kg (RPT10), isoniazid 5 mg/kg (INH5), and bedaquiline 400 mg (BDQ400). Simple randomization will be performed, with a ratio of 1:1:1:1:1:1 for RIF10, RIF20, LFX10-15, RPT10, INH5, and BDQ400. Venous blood and breastmilk samples will be collected for PK assessments of each of the study drugs. Ten participants will be assigned to each arm, with a total participants of 60.
- Conditions
- Tuberculosis Infection, Healthy Volunteer, Breastfeeding
- Being tested
- Standard dose rifampicin, High dose rifampicin, Standard dose isoniazid, Standard dose levofloxacin, Standard dose rifapentine
- Keywords
- Tuberculosis infection, Latent tuberculosis infection, TBI, LTBI, Breastfeeding women, Rifampicin, Levofloxacin, Rifapentine, Isoniazid, Bedaquiline
- Medical subject headings
- Latent Tuberculosis, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard dose rifampicinDrug
Also called RIF10
Single-dose rifampicin at 10 mg/kg body weight
High dose rifampicinDrug
Also called RIF20
Single-dose rifampicin at 20 mg/kg body weight
Standard dose isoniazidDrug
Also called INH5
Single-dose isoniazid at 5 mg/kg body weight
Standard dose levofloxacinDrug
Also called LFX10-15
Single-dose levofloxacin at 10-15 mg/kg body weight
Standard dose rifapentineDrug
Also called RPT10
Single-dose rifapentine at 10 mg/kg body weight
Standard dose bedaquilineDrug
Also called BDQ400
Single-dose bedaquiline at 400 mg
| Study group | Role | What they receive |
|---|---|---|
| 10 mg/kg rifampicin (RIF10) | Experimental | Single-dose rifampicin at 10 mg/kg body weight Receives: Drug: Standard dose rifampicin |
| 20 mg/kg rifampicin (RIF20) | Experimental | Single-dose rifampicin at 20 mg/kg body weight Receives: Drug: High dose rifampicin |
| 5 mg/kg isoniazid (INH5) | Experimental | Single-dose isoniazid at 5 mg/kg body weight Receives: Drug: Standard dose isoniazid |
| 10-15 mg/kg levofloxacin (LFX10-15) | Experimental | Single-dose levofloxacin at 10-15 mg/kg body weight Receives: Drug: Standard dose levofloxacin |
| 10 mg/kg rifapentine (RPT10) | Experimental | Single-dose rifapentine at 10 mg/kg body weight Receives: Drug: Standard dose rifapentine |
| 400 mg bedaquiline (BDQ400) | Experimental | Single-dose bedaquiline at 400 mg Receives: Drug: Standard dose bedaquiline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from 0 to 24 hours (AUC0-24)
Total drug exposures in plasma and breast milk, i.e., the total area under the concentration-time curve from 0 to 24 hours (AUC0-24) after administration of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline.
Measured: Day 1 following single-dose drug administration
Peak concentration (Cmax)
Peak concentration (Cmax) in plasma and breast milk after administration of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline.
Measured: Day 1 following single-dose drug administration
Secondary outcomes (4)
Time to Cmax (Tmax)
Time to Cmax (Tmax) in plasma and breast milk after administration of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline.
Measured: Day 1 following single-dose drug administration
Apparent clearance (CL/F)
Apparent clearance (CL/F) in plasma and breast milk after administration of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline.
Measured: Day 1 following single-dose drug administration
Apparent volume of distribution (Vd/F)
Apparent volume of distribution (Vd/F) in plasma and breast milk after administration of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline.
Measured: Day 1 following single-dose drug administration
Half-life (t1/2)
Half-life (t1/2) in plasma and breast milk after administration of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline.
Measured: Day 1 following single-dose drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Jun 2026
- Primary completion31 Oct 2026
- Study completion31 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis InfectionStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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
- Model description
- Simple randomization will be performed, with a ratio of 1:1:1:1:1:1 for rifampicin at 10 mg/kg (RIF10), rifampicin at 20 mg/kg (RIF20), levofloxacin at 10-15 mg/kg (LFX10-15), rifapentine at 10 mg/kg (RPT10), isoniazid at 5 mg/kg (INH5), and bedaquiline at 40 mg (BDQ400).
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Universitas Padjadjaran
- Responsible party
- Principal investigator, Dick Menzies, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Dick Menzies, MD, Principal investigator, Research Institute of the McGill University Health Centre, Montreal, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069582
- Sponsor's protocol ID
- PRIME_V.2.0
- Acronym
- PRiMe
- Status last verified
- Oct 2026
- First submitted
- 12 Jun 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol and consent form will be available for data sharing once approved by research ethical review board. A detailed plan for data sharing of other study documents and/or data is under definition and will be posted during the study.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma and Breastmilk Exposures to Antituberculosis Drugs in Breastfeeding Women: an Open-label, Randomized, Six-arm, Single-dose, Pharmacokinetic Study
- ClinicalTrials.gov ID
- NCT07069582
- Acronym / sponsor ID
- PRiMe / PRIME_V.2.0
- Conditions
- Tuberculosis Infection, Healthy Volunteer, Breastfeeding
- Keywords
- Tuberculosis infection, Latent tuberculosis infection, TBI, LTBI, Breastfeeding women, Rifampicin, Levofloxacin, Rifapentine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Universitas Padjadjaran
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Oct 2026 (actual)
- Study completion
- 31 Oct 2026 (actual)
- First posted
- 16 Jul 2025 (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 study is a sub-study of the SSTARLET trial (NCT06498414). The overall aim is to assess the pharmacokinetic profiles after taking a single dose of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline in breastfeeding women and the excretion of these drugs in breast milk, with the hope of including breastfeeding women in future clinical trials of TPT, including expanding the inclusion criteria of the SSTARLET trial. In this study, healthy breastfeeding women who fulfill the eligibility criteria will be enrolled from several primary health care centers in Bandung, which will be referred to the TB Research Clinic of the Universitas Padjadjaran, Bandung, Indonesia. Ten participants will be randomized to each of the following six study arms:
- Arm A: Single-dose rifampicin at 10 mg/kg body weight (RIF10).
- Arm B: Single-dose rifampicin at 20 mg/kg body weight (RIF20).
- Arm C: Single-dose isoniazid at 5 mg/kg body weight (INH5).
- Arm D: Single-dose levofloxacin at 10-15 mg/kg body weight (LFX10-15).
- Arm E: Single-dose rifapentine at 10 mg/kg body weight (RPT10).
- Arm F: Single-dose bedaquiline at 400 mg (BDQ400).
Detailed description
Pregnant and breastfeeding women have been largely excluded from recent and ongoing clinical trials due to ethical concerns, limiting their access to the latest advancements in tuberculosis (TB) therapy. To support the development of short, effective tuberculosis preventive treatment (TPT) regimens lasting 1-2 months, a phase 2 adaptive clinical trial (SSTARLET trial) is being planned. This trial will evaluate three experimental regimens: two months of daily double-dose rifampicin; one month of daily levofloxacin and rifapentine; and either one month of daily isoniazid and rifapentine or a bedaquiline-containing regimen. The comparator will be the current standard of four months of daily rifampicin. The safest and shortest regimen will be selected for progression to a phase 3 trial. Inclusion of breastfeeding women in future trials of these regimens is intended; however, limited pharmacokinetic (PK) and safety data exist regarding the excretion of these drugs into breast milk, which is necessary to support their use in this population.
The current study aims to establish the PK profiles of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline in breastfeeding women and the excretion of these drugs in breast milk, with the hope of including breastfeeding women in future clinical trials of TPT. The specific objective of the study is to describe the PK profiles after a single dose of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline in plasma and breast milk of breastfeeding women.
In this study, healthy breastfeeding women who fulfill the eligibility criteria will be enrolled from several primary health care centers in Bandung, which will be referred to the TB Research Clinic of the Universitas Padjadjaran, Bandung, Indonesia.
The primary outcomes in this study are the total drug exposure, i.e., the area under the concentration-time curve from 0 to 24 hours after drug administration (AUC0-24) and peak concentration (Cmax) of single doses of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline in plasma and breastmilk of breastfeeding women, including the breast milk/plasma ratios for AUC0-24 and Cmax to estimate the external exposure of the drugs to breastfed infants. The secondary outcomes are PK measures of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline other than AUC0-24 and Cmax, including time to Cmax (Tmax), elimination rate constant (Ke), elimination half-life (t1/2), apparent clearance (CL/F), and apparent volume of distribution (Vd/F) in plasma and breast milk of breastfeeding women.
The study design is an open-label, randomized, six-arm, single-dose, intensive PK study, that will be performed at the TB Research Clinic of the Universitas Padjadjaran, Bandung, Indonesia. Six oral drug dosages will be evaluated: rifampicin 10 mg/kg (RIF10), rifampicin 20 mg/kg (RIF20), levofloxacin 10-15 mg/kg (LFX10-15), rifapentine 10 mg/kg (RPT10), isoniazid 5 mg/kg (INH5), and bedaquiline 400 mg (BDQ400). Simple randomization will be performed, with a ratio of 1:1:1:1:1:1 for RIF10, RIF20, LFX10-15, RPT10, INH5, and BDQ400. Venous blood and breastmilk samples will be collected for PK assessments of each of the study drugs. Ten participants will be assigned to each arm, with a total participants of 60.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Simple randomization will be performed, with a ratio of 1:1:1:1:1:1 for rifampicin at 10 mg/kg (RIF10), rifampicin at 20 mg/kg (RIF20), levofloxacin at 10-15 mg/kg (LFX10-15), rifapentine at 10 mg/kg (RPT10), isoniazid at 5 mg/kg (INH5), and bedaquiline at 40 mg (BDQ400).
| Arm | Type | Receives |
|---|---|---|
| 10 mg/kg rifampicin (RIF10) | Experimental | Drug: Standard dose rifampicinSingle-dose rifampicin at 10 mg/kg body weight |
| 20 mg/kg rifampicin (RIF20) | Experimental | Drug: High dose rifampicinSingle-dose rifampicin at 20 mg/kg body weight |
| 5 mg/kg isoniazid (INH5) | Experimental | Drug: Standard dose isoniazidSingle-dose isoniazid at 5 mg/kg body weight |
| 10-15 mg/kg levofloxacin (LFX10-15) | Experimental | Drug: Standard dose levofloxacinSingle-dose levofloxacin at 10-15 mg/kg body weight |
| 10 mg/kg rifapentine (RPT10) | Experimental | Drug: Standard dose rifapentineSingle-dose rifapentine at 10 mg/kg body weight |
| 400 mg bedaquiline (BDQ400) | Experimental | Drug: Standard dose bedaquilineSingle-dose bedaquiline at 400 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy breastfeeding women aged 18 years or older, with a minimum of 3 months and a maximum of 24 months after delivery of a healthy baby, and are not currently diagnosed with either TB infection or TB disease.
- Have a body weight between 25 and 100 kg.
- Provide written informed consent.
Key exclusion criteria (8 listed)
- Grade 3-4 abnormalities on baseline blood chemistry tests, including serum alanine aminotransferase (ALT), creatinine, or blood glucose.
- Grade 3-4 abnormalities on baseline hematological tests, including white blood count, platelets, or hemoglobin.
- Contraindications or history of hypersensitivity/intolerance to rifampicin, isoniazid, levofloxacin, rifapentine, or bedaquiline.
- Taking concomitant medications for TB disease, TB infection, diabetes mellitus, hypertension, HIV, cardiac disease or any other chronic diseases.
- Having a breastfed infant who was diagnosed with TB infection or TB disease and is currently on treatment.
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 |
|---|---|---|
| Standard dose rifampicinAlso: RIF10Single-dose rifampicin at 10 mg/kg body weight | Drug | 10 mg/kg rifampicin (RIF10) |
| High dose rifampicinAlso: RIF20Single-dose rifampicin at 20 mg/kg body weight | Drug | 20 mg/kg rifampicin (RIF20) |
| Standard dose isoniazidAlso: INH5Single-dose isoniazid at 5 mg/kg body weight | Drug | 5 mg/kg isoniazid (INH5) |
| Standard dose levofloxacinAlso: LFX10-15Single-dose levofloxacin at 10-15 mg/kg body weight | Drug | 10-15 mg/kg levofloxacin (LFX10-15) |
| Standard dose rifapentineAlso: RPT10Single-dose rifapentine at 10 mg/kg body weight | Drug | 10 mg/kg rifapentine (RPT10) |
| Standard dose bedaquilineAlso: BDQ400Single-dose bedaquiline at 400 mg | Drug | 400 mg bedaquiline (BDQ400) |
Primary outcome
Area under the concentration-time curve from 0 to 24 hours (AUC0-24)
Time frame: Day 1 following single-dose drug administration
Total drug exposures in plasma and breast milk, i.e., the total area under the concentration-time curve from 0 to 24 hours (AUC0-24) after administration of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline.
Peak concentration (Cmax)
Time frame: Day 1 following single-dose drug administration
Peak concentration (Cmax) in plasma and breast milk after administration of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline.
4 secondary outcomes
Time to Cmax (Tmax)
Time frame: Day 1 following single-dose drug administration
Apparent clearance (CL/F)
Time frame: Day 1 following single-dose drug administration
Apparent volume of distribution (Vd/F)
Time frame: Day 1 following single-dose drug administration
Half-life (t1/2)
Time frame: Day 1 following single-dose drug administration
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 2 Nov 2026.
- Individual participant dataSharing planned: Yes. Protocol and consent form will be available for data sharing once approved by research ethical review board. A detailed plan for data sharing of other study documents and/or data is under definition and will be posted during the study.
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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.
Dick Menzies, MD principal investigator
Research Institute of the McGill University Health Centre, Montreal, Canada
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 Standard dose rifampicin, High dose rifampicin and Standard dose isoniazid in people with Tuberculosis Infection and Healthy Volunteer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Indonesia.
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 4 inclusion and 8 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 2 Nov 2026. 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 Indonesia. 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?
Area under the concentration-time curve from 0 to 24 hours (AUC0-24) (time frame: Day 1 following single-dose drug administration). The study lists 2 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 2 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.