HealthyPhase 1NCT04705922
Relative Bioavailability Study and Food Effect Study of TT-00420 (Tinengotinib) Capsule and Tablet Formulations in Healthy Volunteers
A Phase 1 study testing TT-00420 Capsule and TT-00420 Tablet in people with Healthy, run by TransThera Sciences (Nanjing), Inc. at 1 site in United States.
Trial summary
This study is an open-label, 3-way crossover randomized study in adult healthy volunteers to evaluate the relative bioavailability of TT-00420 tablet and capsule formulations and to evaluate food effect on the pharmacokinetics of TT-00420 tablet. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TT-00420 Capsule and TT-00420 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2020to 23 Jul 2021
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects between 18 and 64 years of age inclusive, at the time of signing the informed consent.
- Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and weighs at least 50 kg.
- Healthy as determined by the investigator based on medical history, clinical laboratory results (serum chemistry, hematology, urinalysis, and serology), vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only, if per the investigator discretion, the investigator judges and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male subjects must not donate sperm starting at Screening, throughout the study period and for at least 90 days after final study drug administration.
- Male subjects with female sexual partner(s) of reproductive potential may be enrolled if the male:
- is documented to be surgically sterile (i.e., successfully vasectomized), or
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- agrees to use 2 methods of highly effective contraception and agree to refrain from sperm donation from the time of Screening through 90 days post-doseHighly effective includes male condom with spermicide PLUS an effective contraceptive for the female partner that includes: OCPs, long-acting implantable hormones, injectable hormones, a vaginal ring or IUD
- If female, is of non-childbearing potential, meeting the following requirements:
- pre-menopausal with documentation of surgical sterilization (i.e., hysterectomy, bilateral tubal ligation, bilateral oophorectomy, or bilateral salpingectomy at least 3 months prior to study entry), or
- post-menopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and with follicle-stimulating hormone (FSH) level ≥ 40 mIU/mL at Screening
- Able to sign the informed consent and comply with the protocol.
Who cannot join
- Any history of clinically serious disease.
- Any active or unstable clinically significant medical condition as judged by the Investigator.
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- Hypersensitivity or allergy to any of the study drugs or drugs of similar chemical classes.
- Hypersensitivity or allergy for components of the prescribed meal
- Received any investigational drug within 30 days or 5 half-lives(whichever is longer, if known) before the study.
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- Subject who has undergone major surgery ≤ 2 months before study drug administration.
- Impaired cardiac function including clinically significant arrhythmias or clinically significant abnormality in clinical test, including but not limited to any of the following at Screening and Admission, repeat testing is allowed for verification, at the discretion of the Investigator:
- Heart rate < 45 beats per minute (bpm) or > 90 bpm.
- Systolic blood pressure (SBP) < 90 mmHg or > 140 mmHg; diastolic blood pressure (DBP) < 50 mmHg or > 90 mmHg.
- Average of the 3 QT intervals corrected using Fridericia's formula (QTcF) > 450 milliseconds.
- Troponin I at screening > upper limit of normal (ULN).
- Second degree or higher Atrioventricular block on ECG.
- Subject who has a known history of, or a positive test result for, hepatitis B surface antigen (HBsAg), immunoglobulin M (IgM) antibody to hepatitis B core antibody (anti-HBc) (IgM anti-HBc), hepatitis C virus antibody (anti-HCV), or human immunodeficiency virus (HIV) types 1 or 2, or syphilis at Screening.
- Subject with a history of severe visual diseases; or visual changes including flushing lights, blurry vision, color changes, or other visual changes.
- Subject who has used prescription or over-the-counter (OTC) medication (other than ≤ 2 g/day paracetamol [acetaminophen] or ≤ 800-mg/day ibuprofen), vitamins, or herbal remedies, within 2 weeks or 5 half-lives (if known) before study drug administration, whichever is longer.
- Subject who has had a loss of more than 100 mL blood (e.g., a blood donation) within 2 months before study drug administration, or has received any blood, plasma, or platelet transfusions within 3 months before Admission, or plans to donate blood during the study or within 3 months after the study.
- Subject who has a history of alcohol abuse (defined as an alcohol intake more than 21 units for males and 14 units for females per week) or a history of drug abuse within the 6 months before study drug administration, or a history of substance abuse deemed significant by the Investigator.
- Subject who smokes cigarettes or uses other nicotine-containing products (e.g., snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers), and has done so in the 3 months prior to Screening.
- Subject who has a positive test for alcohol or drugs of abuse (opiates, methadone, buprenorphine, methamphetamine, cocaine, cannabinoids, amphetamines, or cotinine) at Screening or Admission.
- Subject is unable to complete this study for other reasons or the Investigator believes that he or she should be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-Center, Open-Label, 3-Way Crossover, Randomized Single Dose Study to Evaluate the Food Effect on the Pharmacokinetics of TT-00420 Tablet and to Determine the Relative Bioavailability of TT-00420 Tablet Versus TT-00420 Capsule in Adult Healthy Volunteers
This study is an open-label, 3-way crossover randomized study in adult healthy volunteers to evaluate the relative bioavailability of TT-00420 tablet and capsule formulations and to evaluate food effect on the pharmacokinetics of TT-00420 tablet.
Read the detailed description
Subjects will be randomized to one of three treatment sequences. Each sequence will contain up to 8 subjects. In each treatment sequence, subjects undergo a baseline/screening period, three treatment periods, and a follow-up visit.
Subjects will be administered a single dose of TT-00420 on Day 1 of either TT-00420 tablet under fed condition, TT-00420 tablet under fasting condition, or capsule under fasting condition and crossed over after at least a 14-day washout period.
- Conditions
- Healthy
- Being tested
- TT-00420 Capsule, TT-00420 Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TT-00420 CapsuleDrug
TT-00420 capsule formulation, administered orally
TT-00420 TabletDrug
TT-00420 tablet formulation, administered orally
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 [TT-00420 tablet, fed; TT-00420 tablet, fasted; TT-00420 capsule, fasted] | Experimental | Participants will receive a single dose of TT-00420 tablet under fed conditions, followed by a single dose of TT-00420 tablet under fasted conditions, followed by a single dose of TT-00420 capsule under fasted conditions. There will be at least a 14-day wash-out period between each dose. Receives: Drug: TT-00420 Capsule; Drug: TT-00420 Tablet |
| Sequence 2 [TT-00420 tablet, fasted; TT-00420 capsule, fed; TT-00420 tablet, fed] | Experimental | Participants will receive a single dose of TT-00420 tablet under fasted conditions, followed by a single dose of TT-00420 capsule under fasted conditions, followed by a single dose of TT-00420 tablet under fed conditions. There will be at least a 14-day wash-out period between each dose. Receives: Drug: TT-00420 Capsule; Drug: TT-00420 Tablet |
| Sequence 3 [TT-00420 capsule, fasted; TT-00420 tablet, fed; TT-00420 tablet, fasted] | Experimental | Participants will receive a single dose of TT-00420 capsule under fasted conditions, followed by a single dose of TT-00420 tablet under fed conditions, followed by a single dose of TT-00420 tablet under fasted conditions. There will be at least a 14-day wash-out period between each dose. Receives: Drug: TT-00420 Capsule; Drug: TT-00420 Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC0-∞) of TT-00420
Blood samples will be collected at indicated time points for pharmacokinetic analysis of TT-00420.
Measured: From pre-dose up to 240 hours post-dose each period (each period is 14 days)
Area under the curve (AUC0-t) of TT-00420
Blood samples will be collected at indicated time points for pharmacokinetic analysis of TT-00420.
Measured: From pre-dose up to 240 hours post-dose each period (each period is 14 days)
Maximum observed concentration (Cmax) of TT-00420
Blood samples will be collected at indicated time points for pharmacokinetic analysis of TT-00420.
Measured: From pre-dose up to 240 hours post-dose each period (each period is 14 days)
Secondary outcomes (10)
Number of participants with adverse events (AEs)
Measured: From admission up to 10 days following discharge
Incidence of abnormal physical examinations
Measured: At baseline and from admission to discharge, up to 12 days per period (each period is 14 days)
Incidence of abnormal clinical laboratory tests
Measured: At baseline and from admission to discharge, up to 12 days per period (each period is 14 days)
Incidence of abnormal vital signs
Measured: At baseline and from admission to discharge, up to 12 days per period (each period is 14 days)
Incidence of abnormal weight
Measured: At baseline and from admission to discharge, up to 12 days per period (each period is 14 days)
Incidence of abnormal 12-lead electrocardiogram
Measured: At baseline and from admission to discharge, up to 12 days per period (each period is 14 days)
Half life (t1/2) of TT-00420
Blood samples will be collected at indicated time points for pharmacokinetic analysis of TT-00420.
Measured: From pre-dose up to 240 hours post-dose each period (each period is 14 days)
Time of maximum concentration (tmax) of TT-00420
Blood samples will be collected at indicated time points for pharmacokinetic analysis of TT-00420.
Measured: From pre-dose up to 240 hours post-dose each period (each period is 14 days)
Volume of distribution (Vd/F) of TT-00420
Blood samples will be collected at indicated time points for pharmacokinetic analysis of TT-00420.
Measured: From pre-dose up to 240 hours post-dose each period (each period is 14 days)
Clearance (CL/F) of TT-00420
Blood samples will be collected at indicated time points for pharmacokinetic analysis of TT-00420.
Measured: From pre-dose up to 240 hours post-dose each period (each period is 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start29 Dec 2020
- Primary completion7 Mar 2021
- Study completion23 Jul 2021
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- TransThera Sciences (Nanjing), Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohamed Al-Ibrahim, Principal investigator, Pharmaron CPC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705922
- Sponsor's protocol ID
- TT420HV1102
- Status last verified
- Dec 2023
- First submitted
- 6 Jan 2021
- Last updated
- 3 Jan 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 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Open-Label, 3-Way Crossover, Randomized Single Dose Study to Evaluate the Food Effect on the Pharmacokinetics of TT-00420 Tablet and to Determine the Relative Bioavailability of TT-00420 Tablet Versus TT-00420 Capsule in Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04705922
- Acronym / sponsor ID
- TT420HV1102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- TransThera Sciences (Nanjing), Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 7 Mar 2021 (actual)
- Study completion
- 23 Jul 2021 (actual)
- First posted
- 12 Jan 2021 (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 an open-label, 3-way crossover randomized study in adult healthy volunteers to evaluate the relative bioavailability of TT-00420 tablet and capsule formulations and to evaluate food effect on the pharmacokinetics of TT-00420 tablet.
Detailed description
Subjects will be randomized to one of three treatment sequences. Each sequence will contain up to 8 subjects. In each treatment sequence, subjects undergo a baseline/screening period, three treatment periods, and a follow-up visit.
Subjects will be administered a single dose of TT-00420 on Day 1 of either TT-00420 tablet under fed condition, TT-00420 tablet under fasting condition, or capsule under fasting condition and crossed over after at least a 14-day washout period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 [TT-00420 tablet, fed; TT-00420 tablet, fasted; TT-00420 capsule, fasted] | Experimental | Drug: TT-00420 Capsule, Drug: TT-00420 TabletParticipants will receive a single dose of TT-00420 tablet under fed conditions, followed by a single dose of TT-00420 tablet under fasted conditions, followed by a single dose of TT-00420 capsule under fasted conditions. There will be at least a 14-day wash-out period between each dose. |
| Sequence 2 [TT-00420 tablet, fasted; TT-00420 capsule, fed; TT-00420 tablet, fed] | Experimental | Drug: TT-00420 Capsule, Drug: TT-00420 TabletParticipants will receive a single dose of TT-00420 tablet under fasted conditions, followed by a single dose of TT-00420 capsule under fasted conditions, followed by a single dose of TT-00420 tablet under fed conditions. There will be at least a 14-day wash-out period between each dose. |
| Sequence 3 [TT-00420 capsule, fasted; TT-00420 tablet, fed; TT-00420 tablet, fasted] | Experimental | Drug: TT-00420 Capsule, Drug: TT-00420 TabletParticipants will receive a single dose of TT-00420 capsule under fasted conditions, followed by a single dose of TT-00420 tablet under fed conditions, followed by a single dose of TT-00420 tablet under fasted conditions. There will be at least a 14-day wash-out period between each dose. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or female subjects between 18 and 64 years of age inclusive, at the time of signing the informed consent.
- Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and weighs at least 50 kg.
- Healthy as determined by the investigator based on medical history, clinical laboratory results (serum chemistry, hematology, urinalysis, and serology), vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only, if per the investigator discretion, the investigator judges and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male subjects must not donate sperm starting at Screening, throughout the study period and for at least 90 days after final study drug administration.
- Male subjects with female sexual partner(s) of reproductive potential may be enrolled if the male:
Key exclusion criteria (21 listed)
- Any history of clinically serious disease.
- Any active or unstable clinically significant medical condition as judged by the Investigator.
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- Hypersensitivity or allergy to any of the study drugs or drugs of similar chemical classes.
- Hypersensitivity or allergy for components of the prescribed meal
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 |
|---|---|---|
| TT-00420 CapsuleTT-00420 capsule formulation, administered orally | Drug | Sequence 1 [TT-00420 tablet, fed; TT-00420 tablet, fasted; TT-00420 capsule, fasted], Sequence 2 [TT-00420 tablet, fasted; TT-00420 capsule, fed; TT-00420 tablet, fed], Sequence 3 [TT-00420 capsule, fasted; TT-00420 tablet, fed; TT-00420 tablet, fasted] |
| TT-00420 TabletTT-00420 tablet formulation, administered orally | Drug | Sequence 1 [TT-00420 tablet, fed; TT-00420 tablet, fasted; TT-00420 capsule, fasted], Sequence 2 [TT-00420 tablet, fasted; TT-00420 capsule, fed; TT-00420 tablet, fed], Sequence 3 [TT-00420 capsule, fasted; TT-00420 tablet, fed; TT-00420 tablet, fasted] |
Primary outcome
Area under the curve (AUC0-∞) of TT-00420
Time frame: From pre-dose up to 240 hours post-dose each period (each period is 14 days)
Blood samples will be collected at indicated time points for pharmacokinetic analysis of TT-00420.
Area under the curve (AUC0-t) of TT-00420
Time frame: From pre-dose up to 240 hours post-dose each period (each period is 14 days)
Blood samples will be collected at indicated time points for pharmacokinetic analysis of TT-00420.
Maximum observed concentration (Cmax) of TT-00420
Time frame: From pre-dose up to 240 hours post-dose each period (each period is 14 days)
Blood samples will be collected at indicated time points for pharmacokinetic analysis of TT-00420.
10 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: From admission up to 10 days following discharge
Incidence of abnormal physical examinations
Time frame: At baseline and from admission to discharge, up to 12 days per period (each period is 14 days)
Incidence of abnormal clinical laboratory tests
Time frame: At baseline and from admission to discharge, up to 12 days per period (each period is 14 days)
Incidence of abnormal vital signs
Time frame: At baseline and from admission to discharge, up to 12 days per period (each period is 14 days)
Incidence of abnormal weight
Time frame: At baseline and from admission to discharge, up to 12 days per period (each period is 14 days)
Incidence of abnormal 12-lead electrocardiogram
Time frame: At baseline and from admission to discharge, up to 12 days per period (each period is 14 days)
Half life (t1/2) of TT-00420
Time frame: From pre-dose up to 240 hours post-dose each period (each period is 14 days)
Time of maximum concentration (tmax) of TT-00420
Time frame: From pre-dose up to 240 hours post-dose each period (each period is 14 days)
Volume of distribution (Vd/F) of TT-00420
Time frame: From pre-dose up to 240 hours post-dose each period (each period is 14 days)
Clearance (CL/F) of TT-00420
Time frame: From pre-dose up to 240 hours post-dose each period (each period is 14 days)
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 3 Jan 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.
Mohamed Al-Ibrahim principal investigator
Pharmaron CPC
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 TT-00420 Capsule and TT-00420 Tablet in people with Healthy, run by TransThera Sciences (Nanjing), 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 11 inclusion and 21 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 3 Jan 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?
Area under the curve (AUC0-∞) of TT-00420 (time frame: From pre-dose up to 240 hours post-dose each period (each period is 14 days)). The study lists 3 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 3 Jan 2024.