Healthy VolunteersPhase 1NCT03704675
Effect of Food on the Pharmacokinetics of TEW-7197 in Healthy Subjects
A Phase 1 study testing TEW-7197 in people with Healthy Volunteers, run by MedPacto, Inc. at 1 site in South Korea.
Trial summary
Participants in this study will receive 200 milligram (mg) TEW-7197 taken at 7days apart. One dose will be given under fasting . The Other dose will be given with a high fat meal. The study will evaluate the effect of a high fat meal on how much of the drug gets into the blood stream. Side effects will be documented. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TEW-7197
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Aug 2018to 20 Oct 2018
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy sterile males
- BMI 18.0kg/m2 - 27.0 kg/m2
- No congenital or chronic disease and no pathological symptoms or pathological findings
- Investigator confirm that the subject is eligible through a medical examination (medical history taking ,vital signs, ECG, cardiac ultrasonography, blood science)
Who cannot join
- Has pathological symptoms or pathological findings
- Has a history of disease that may affect the absorption, distribution, metabolism and excretion of a drug
- SBP>140 or <90 mmhg , DBP>90 or <60mmHg ,Pulse>100
- No abnormal Clinical Lab findings
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial for the Safety, Tolerability, and Pharmacokinetics of TEW-7197 Under Fed or Fasting in Healthy Male Subjects
Participants in this study will receive 200 milligram (mg) TEW-7197 taken at 7days apart. One dose will be given under fasting . The Other dose will be given with a high fat meal. The study will evaluate the effect of a high fat meal on how much of the drug gets into the blood stream. Side effects will be documented. This study will last approximately 2weeks not including screening.
Read the detailed description
Through screening (D-30 ~ D-1) prior to the first dose of the investigational product, a total of 16 subjects (Group 1: 8 subjects, Group 2: 8 subjects) who were eligible for the inclusion criteria and exclusion criteria were enrolled. This clinical study has a randomized, open, single dose, 2-sequence, 2-period cross-over design and TEW-7197 50 mg x 4 tablets were administered as a single dose in the same individual for 2 periods after fasting or a high fat diet, and each period was repeated with an interval of at least 1 week of wash-out. Pharmacokinetics and safety were evaluated in all subjects according to the planned schedule
- Conditions
- Healthy Volunteers
- Being tested
- TEW-7197
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEW-7197Drug
Also called Vactosertib
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Group I (Fasted->Fed) | Experimental | Group 1 received a single oral dose in a fasting condition in Period 1, followed by a single oral dose after a high-fat diet in Period 2 Receives: Drug: TEW-7197 |
| Group II(Fed->Fasted) | Experimental | Group 2 received a single oral dose after a high-fat diet in Period 1, followed by a single oral in a fasting condition in Period 2 Receives: Drug: TEW-7197 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics:Maximum Concentration (Cmax)
Maximum Concentration (Cmax)
Measured: Pre-dose through 24 hours post-dose in each period of the. study
Pharmacokinetics:Area Under the Concentration Curve (AUC)
Area Under the Concentration Curve (AUC) of TEW-7197
Measured: Pre-dose through 24 hours post-dose in each period of the. study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start8 Aug 2018
- Primary completion9 Sep 2018
- Study completion20 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedPacto, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sunjin Hwang, MD, Study director, MedPacto, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704675
- Sponsor's protocol ID
- MP-VAC-105
- Status last verified
- Apr 2020
- First submitted
- 10 Oct 2018
- Last updated
- 14 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for the Safety, Tolerability, and Pharmacokinetics of TEW-7197 Under Fed or Fasting in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03704675
- Acronym / sponsor ID
- MP-VAC-105
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- MedPacto, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 9 Sep 2018 (actual)
- Study completion
- 20 Oct 2018 (actual)
- First posted
- 15 Oct 2018 (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.
Participants in this study will receive 200 milligram (mg) TEW-7197 taken at 7days apart. One dose will be given under fasting . The Other dose will be given with a high fat meal. The study will evaluate the effect of a high fat meal on how much of the drug gets into the blood stream. Side effects will be documented. This study will last approximately 2weeks not including screening.
Detailed description
Through screening (D-30 ~ D-1) prior to the first dose of the investigational product, a total of 16 subjects (Group 1: 8 subjects, Group 2: 8 subjects) who were eligible for the inclusion criteria and exclusion criteria were enrolled. This clinical study has a randomized, open, single dose, 2-sequence, 2-period cross-over design and TEW-7197 50 mg x 4 tablets were administered as a single dose in the same individual for 2 periods after fasting or a high fat diet, and each period was repeated with an interval of at least 1 week of wash-out. Pharmacokinetics and safety were evaluated in all subjects according to the planned schedule
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Fasted->Fed) | Experimental | Drug: TEW-7197Group 1 received a single oral dose in a fasting condition in Period 1, followed by a single oral dose after a high-fat diet in Period 2 |
| Group II(Fed->Fasted) | Experimental | Drug: TEW-7197Group 2 received a single oral dose after a high-fat diet in Period 1, followed by a single oral in a fasting condition in Period 2 |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy sterile males
- BMI 18.0kg/m2 - 27.0 kg/m2
- No congenital or chronic disease and no pathological symptoms or pathological findings
- Investigator confirm that the subject is eligible through a medical examination (medical history taking ,vital signs, ECG, cardiac ultrasonography, blood science)
Key exclusion criteria (4 listed)
- Has pathological symptoms or pathological findings
- Has a history of disease that may affect the absorption, distribution, metabolism and excretion of a drug
- SBP>140 or <90 mmhg , DBP>90 or <60mmHg ,Pulse>100
- No abnormal Clinical Lab findings
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 |
|---|---|---|
| TEW-7197Also: VactosertibAdministered orally | Drug | Group I (Fasted->Fed), Group II(Fed->Fasted) |
Primary outcome
Pharmacokinetics:Maximum Concentration (Cmax)
Time frame: Pre-dose through 24 hours post-dose in each period of the. study
Maximum Concentration (Cmax)
Pharmacokinetics:Area Under the Concentration Curve (AUC)
Time frame: Pre-dose through 24 hours post-dose in each period of the. study
Area Under the Concentration Curve (AUC) of TEW-7197
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 14 Apr 2020.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Sunjin Hwang, MD study director
MedPacto, Inc.
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 TEW-7197 in people with Healthy Volunteers, run by MedPacto, 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 4 inclusion and 4 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 14 Apr 2020. 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. 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?
Pharmacokinetics:Maximum Concentration (Cmax) (time frame: Pre-dose through 24 hours post-dose in each period of the. study). 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 14 Apr 2020; AzTrials last refreshed its copy on 8 Nov 2026.