Healthy Male SubjectsPhase 1NCT06087978
Study of RPT193 in Healthy Adult Male Subjects
A Phase 1 study testing 14C RPT193 in people with Healthy Male Subjects, run by RAPT Therapeutics, Inc., a member of the GSK plc group of companies at 1 site in United States.
Trial summary
Phase 1, open-label, absorption, metabolism, excretion, and mass balance study. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Subjects
- What is being tested?
- 14C RPT193
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2023to 12 Oct 2023
- 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to dosing
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening
Who cannot join
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit
- History or presence of clinically significant medical or psychiatric condition or disease
- History or presence of alcohol or drug abuse within the past 2 years prior to dosing
- History or presence of:
- Gastrointestinal ulcers, or history of other significant GI diseases
- Malignancy within the last 5 years, with the exception of successfully treated basal cell carcinoma.
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- Clinically significant history of angina, myocardial infarction, syncope, clinically significant cardiac arrhythmias, left ventricular hypertrophy, cardiomyopathy, or any other cardiovascular abnormality
- Ongoing or recent (within 30 days prior to RPT193 administration) bacterial, fungal, or viral infection requiring therapy
- Known family history of sudden death.
- Positive for human immunodeficiency virus, hepatitis B, hepatitis C
- Unwilling to abstain from alcohol, xanthane-containing beverages or food or foods containing grapefruit/Seville orange prior to admission
- Received radiolabeled substances or exposed to radiation sources over past 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study to Characterize the Absorption, Metabolism, Excretion (ADME), and Mass Balance of a Single Oral Dose of [14C]-RPT193 in Healthy Adult Male Subjects
Phase 1, open-label, absorption, metabolism, excretion, and mass balance study.
Read the detailed description
A study of RPT193 in healthy volunteers to evaluate the route(s) of elimination and overall mass balance of RPT193 in urine and feces
- Conditions
- Healthy Male Subjects
- Being tested
- 14C RPT193
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14C RPT193Drug
Radiolabelled RPT193
| Study group | Role | What they receive |
|---|---|---|
| 14C RPT193 400 mg | Experimental | Radiolabelled RPT193 Receives: Drug: 14C RPT193 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Route(s) of elimination 1
Amount (in mass equivalents of parent drug) of radioactive drug excreted as TRA in urine and feces
Measured: 14 days
Route(s) of elimination 2
Percent (%) of radioactive drug excreted as TRA in urine and feces
Measured: 14 days
Quantitate total radioactivity (TRA)
Percent (%) of each drug-related material (parent and each metabolite) in whole blood, plasma, urine and feces
Measured: 14 days
Characterize pharmacokinetics (PK) profile of RPT193
Calculation of area under the curve (AUC) in plasma and urine
Measured: 14 days
Characterize pharmacokinetics (PK) profile of RPT193
Calculation of peak plasma concentration (Cmax) in plasma and urine
Measured: 14 days
Characterize pharmacokinetics (PK) profile of RPT193
Calculation of time to peak plasma concentration (Tmax) in plasma and urine
Measured: 14 days
Characterize pharmacokinetics (PK) profile of RPT193
Calculation of half-life in plasma and urine
Measured: 14 days
Characterize pharmacokinetics (PK) profile of RPT193
Calculation of elimination constant in plasma and urine
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start5 Jul 2023
- Primary completion12 Oct 2023
- Study completion12 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male SubjectsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAPT Therapeutics, Inc., a member of the GSK plc group of companies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087978
- Sponsor's protocol ID
- RPT193-04
- Status last verified
- Nov 2023
- First submitted
- 4 Oct 2023
- Last updated
- 29 Nov 2023
- 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 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Characterize the Absorption, Metabolism, Excretion (ADME), and Mass Balance of a Single Oral Dose of [14C]-RPT193 in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT06087978
- Acronym / sponsor ID
- RPT193-04
- Conditions
- Healthy Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- RAPT Therapeutics, Inc., a member of the GSK plc group of companiesIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 12 Oct 2023 (actual)
- Study completion
- 12 Oct 2023 (actual)
- First posted
- 18 Oct 2023 (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.
Phase 1, open-label, absorption, metabolism, excretion, and mass balance study.
Detailed description
A study of RPT193 in healthy volunteers to evaluate the route(s) of elimination and overall mass balance of RPT193 in urine and feces
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14C RPT193 400 mg | Experimental | Drug: 14C RPT193Radiolabelled RPT193 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to dosing
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening
Key exclusion criteria (12 listed)
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit
- History or presence of clinically significant medical or psychiatric condition or disease
- History or presence of alcohol or drug abuse within the past 2 years prior to dosing
- History or presence of:
- Positive for human immunodeficiency virus, hepatitis B, hepatitis C
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 |
|---|---|---|
| 14C RPT193Radiolabelled RPT193 | Drug | 14C RPT193 400 mg |
Primary outcome
Route(s) of elimination 1
Time frame: 14 days
Amount (in mass equivalents of parent drug) of radioactive drug excreted as TRA in urine and feces
Route(s) of elimination 2
Time frame: 14 days
Percent (%) of radioactive drug excreted as TRA in urine and feces
Quantitate total radioactivity (TRA)
Time frame: 14 days
Percent (%) of each drug-related material (parent and each metabolite) in whole blood, plasma, urine and feces
Characterize pharmacokinetics (PK) profile of RPT193
Time frame: 14 days
Calculation of area under the curve (AUC) in plasma and urine
Characterize pharmacokinetics (PK) profile of RPT193
Time frame: 14 days
Calculation of peak plasma concentration (Cmax) in plasma and urine
Characterize pharmacokinetics (PK) profile of RPT193
Time frame: 14 days
Calculation of time to peak plasma concentration (Tmax) in plasma and urine
Characterize pharmacokinetics (PK) profile of RPT193
Time frame: 14 days
Calculation of half-life in plasma and urine
Characterize pharmacokinetics (PK) profile of RPT193
Time frame: 14 days
Calculation of elimination constant in plasma and urine
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 29 Nov 2023.
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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 14C RPT193 in people with Healthy Male Subjects, run by RAPT Therapeutics, Inc., a member of the GSK plc group of companies 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 2 inclusion and 12 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 29 Nov 2023. 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?
Route(s) of elimination 1 (time frame: 14 days). 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 29 Nov 2023.