Healthy Adult SubjectPhase 1NCT06562088
A Drug-Drug Interaction (DDI) Study of HDM1002 With Rifampicin and Itraconazole in Healthy Subjects
A Phase 1 study testing HDM1002 and rifampicin and HDM1002 and itraconazole in people with Healthy Adult Subject, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to characterize the effect of rifampicin and itraconazole on the PK of single dose of HDM1002 in healthy adult subjects. The safety and tolerability of HDM1002 and rifampicin or itraconazole when given separately or together will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subject
- What is being tested?
- HDM1002 and rifampicin and HDM1002 and itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2024to 30 Dec 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results during the screening period, the investigator considers the subject to be in good general health.
- Age range of 18-45 years old (including range), no limit to gender.
- Eligible male participant weighed ≥50.0 kg, eligible female participant weighed ≥45.0 kg, and had a body mass index (BMI) within the range of 19.0 - 32.0 kg/m2 (including cut-off values).
Who cannot join
- Participant has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin≥50 ng/L during the screening period.
- History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
- History of acute cholecystitis within 3 month prior to initiation of screening period.
- Participant judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.
- History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.
- During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant .
Show all 9Show fewer
- Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug.
- History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission.
- Presence of clinically significant ECG results judged by the investigator at screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label, Parallel, Fixed-Sequence Study to Evaluate the Effect of Repeated Administration of Rifampicin or Itraconazole on the Pharmacokinetics of HDM1002 in Healthy Adult Chinese Subjects
The purpose of this study is to characterize the effect of rifampicin and itraconazole on the PK of single dose of HDM1002 in healthy adult subjects. The safety and tolerability of HDM1002 and rifampicin or itraconazole when given separately or together will also be evaluated.
- Conditions
- Healthy Adult Subject
- Being tested
- HDM1002 and rifampicin, HDM1002 and itraconazole
- Keywords
- HDM1002 tablet, Glucagon-Like Peptide-1 Receptor Agonists
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM1002 and rifampicinDrug
Administered orally
HDM1002 and itraconazoleDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: HDM1002 and rifampicin | Experimental | Part 1: Single dose of HDM1002
Part 2: Once daily dose of rifampicin with single dose of HDM1002 Receives: Drug: HDM1002 and rifampicin |
| Cohort 2: HDM1002 and itraconazole | Experimental | Part 1: Single dose of HDM1002
Part 2: Once daily dose of itraconazole with single dose of HDM1002 Receives: Drug: HDM1002 and itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC[0-∞] of HDM1002
Pharmacokinetics (PK) parameter : Area under the curve from time 0 hour to ∞
Measured: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
AUC[0-24 h] of HDM1002
PK parameter : Area under the curve from time 0 to 24 hour
Measured: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Cmax of HDM1002
PK parameter : Maximum observed concentration
Measured: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
AUC[0-t] of HDM1002
PK parameters : Area under the curve from time 0 to t hour
Measured: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Tmax of HDM1002
PK parameters : Time to maximum plasma concentration
Measured: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
t1/2 of HDM1002
PK parameters : Half life
Measured: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
CL/F of HDM1002
PK parameters : Apparent Clearance
Measured: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Vz/F of HDM1002
PK parameters : Apparent volume of distribution
Measured: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Secondary outcomes (9)
AUC[0-∞] of HDM1002 metabolites
PK parameters : Area under the curve from time 0 hour to ∞
Measured: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
AUC[0-24 h] of HDM1002 metabolites
PK parameters : Area under the curve from time 0 to 24 hour
Measured: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Cmax of HDM1002 metabolites
PK parameters : Maximum observed concentration
Measured: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
AUC[0-t] of HDM1002 metabolites
PK parameters : Area under the curve from time 0 to t hour
Measured: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Tmax of HDM1002 metabolites
PK parameters : Time to maximum plasma concentration
Measured: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
t1/2 of HDM1002 metabolites
PK parameters: Half life
Measured: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
CL/F of HDM1002 metabolites
PK parameters : Apparent Clearance
Measured: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Vz/F of HDM1002 metabolites
PK parameters : Apparent volume of distribution
Measured: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Adverse events (AEs)
Number of subjects reporting AEs
Measured: Cohort 1: Day 1-Day 16; Cohort 2: Day 1-Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start16 Aug 2024 (estimated)
- Primary completion19 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult SubjectStudies of the same condition, open and under way.
- More trials run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.The 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562088
- Sponsor's protocol ID
- HDM1002-105
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Parallel, Fixed-Sequence Study to Evaluate the Effect of Repeated Administration of Rifampicin or Itraconazole on the Pharmacokinetics of HDM1002 in Healthy Adult Chinese Subjects
- ClinicalTrials.gov ID
- NCT06562088
- Acronym / sponsor ID
- HDM1002-105
- Conditions
- Healthy Adult Subject
- Keywords
- HDM1002 tablet, Glucagon-Like Peptide-1 Receptor Agonists
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2024 (estimated)
- Primary completion
- 19 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 20 Aug 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.
The purpose of this study is to characterize the effect of rifampicin and itraconazole on the PK of single dose of HDM1002 in healthy adult subjects. The safety and tolerability of HDM1002 and rifampicin or itraconazole when given separately or together will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: HDM1002 and rifampicin | Experimental | Drug: HDM1002 and rifampicinPart 1: Single dose of HDM1002 Part 2: Once daily dose of rifampicin with single dose of HDM1002 |
| Cohort 2: HDM1002 and itraconazole | Experimental | Drug: HDM1002 and itraconazolePart 1: Single dose of HDM1002 Part 2: Once daily dose of itraconazole with single dose of HDM1002 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results during the screening period, the investigator considers the subject to be in good general health.
- Age range of 18-45 years old (including range), no limit to gender.
- Eligible male participant weighed ≥50.0 kg, eligible female participant weighed ≥45.0 kg, and had a body mass index (BMI) within the range of 19.0 - 32.0 kg/m2 (including cut-off values).
Key exclusion criteria (9 listed)
- Participant has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin≥50 ng/L during the screening period.
- History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
- History of acute cholecystitis within 3 month prior to initiation of screening period.
- Participant judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.
- History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.
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 |
|---|---|---|
| HDM1002 and rifampicinAdministered orally | Drug | Cohort 1: HDM1002 and rifampicin |
| HDM1002 and itraconazoleAdministered orally | Drug | Cohort 2: HDM1002 and itraconazole |
Primary outcome
AUC[0-∞] of HDM1002
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Pharmacokinetics (PK) parameter : Area under the curve from time 0 hour to ∞
AUC[0-24 h] of HDM1002
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
PK parameter : Area under the curve from time 0 to 24 hour
Cmax of HDM1002
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
PK parameter : Maximum observed concentration
AUC[0-t] of HDM1002
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
PK parameters : Area under the curve from time 0 to t hour
Tmax of HDM1002
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
PK parameters : Time to maximum plasma concentration
t1/2 of HDM1002
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
PK parameters : Half life
CL/F of HDM1002
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
PK parameters : Apparent Clearance
Vz/F of HDM1002
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
PK parameters : Apparent volume of distribution
9 secondary outcomes
AUC[0-∞] of HDM1002 metabolites
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
AUC[0-24 h] of HDM1002 metabolites
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Cmax of HDM1002 metabolites
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
AUC[0-t] of HDM1002 metabolites
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Tmax of HDM1002 metabolites
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
t1/2 of HDM1002 metabolites
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
CL/F of HDM1002 metabolites
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Vz/F of HDM1002 metabolites
Time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Adverse events (AEs)
Time frame: Cohort 1: Day 1-Day 16; Cohort 2: Day 1-Day 13
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
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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.
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 HDM1002 and rifampicin and HDM1002 and itraconazole in people with Healthy Adult Subject, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 20 Aug 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei hu (0551-65997164, hwgcp@ayefy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC[0-∞] of HDM1002 (time frame: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13). The study lists 8 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 20 Aug 2024.