InfluenzaPhase 1NCT04385420
Phase 1 Study of ATR-002
A Phase 1 study testing ATR-002 MEK Inhibitor in people with Influenza, run by Atriva Therapeutics GmbH at 1 site in Belgium.
Trial summary
This was a combination of a single ascending dose (SAD) study to evaluate the safety, tolerability, and PK of 3 oral doses of a MEK inhibitor and a multiple ascending dose (MAD) study of 3 oral doses of a MEK inhibitor. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- ATR-002 MEK Inhibitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Apr 2019to 26 Aug 2019
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, between 18 and 55 years old, extremes included;
- Weighed at least 50 kg and had a body mass index (BMI) within normal range: 18.0≤ BMI <31.0 kg/m2;
- In good physical and mental health as determined on the basis of medical history and general physical examination performed at screening;
- Haematology and chemistry parameters, pulse rate and/or blood pressure, and ECG within the reference range for the population studied, or showing no clinically relevant deviations, as judged by the Investigator;
- Negative urine test for selected drugs of abuse at screening and upon check-in at the clinical site; Note: Subjects could not consume poppy-seeds within 24h before screening and before each urine drug screening because this could falsify the results of the opiate urine drug test.
- Negative alcohol breath test at screening and upon check-in at the clinical site;
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- Negative hepatitis panel (including hepatitis B surface antigen [HBsAg] and anti hepatitis C virus [HCV] antibodies) and negative human immunodeficiency virus (HIV) antibody screens;
- Female subjects had to be of non-childbearing potential, as follows:
- At least 1 year post-menopausal (amenorrhea >12 months in the absence of an alternative medical cause and follicle-stimulating hormone >30 mIU/mL in women not using hormonal contraception or hormonal replacement therapy) prior to screening;
- Surgically sterile (bilateral oophorectomy, hysterectomy, bilateral salpingectomy, or bilateral tubal ligation);
- To protect partners from possible exposure to study medication in semen, male subjects had to use a condom during the study, even if they had a vasectomy or their partner was not of childbearing potential.
- Note: medically acceptable methods of contraception that could be used by the partner included combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, and etonogestrel implant;
- Willing to adhere to the prohibitions and restrictions specified in the protocol (see Appendix 16.1.1);
- Ability to comprehend the nature of the study and any hazards of participating in it. Ability to communicate satisfactorily with the Investigator and to participate in, and comply with the requirements of, the entire study;
- Informed Consent Form (ICF) signed voluntarily before any study-related procedure was performed, indicating that the subject understood the purpose of and procedures required for the study and was willing to participate in the study.
Who cannot join
- Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-study screening assessment that could interfere with the objectives of the study or the safety of the subject;
- Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the subject's participation in the study or make it unnecessarily hazardous;
- A condition that, in the opinion of the Investigator, could compromise the well being of the subject or course of the study, or prevent the subject from meeting or performing any study requirements;
- Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, cancer, or history of any psychotic mental illness;
- Respiratory tract infection within 4 weeks before the screening visit;
- History of surgery or medical intervention, or planned surgery or medical intervention, that could interfere with the objectives of the study or the safety of the subject;
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- Presence or history of severe adverse reaction to any drug, or sensitivity to components of the study medication;
- Use of a prescription or over-the-counter medicine, with the exception of acetaminophen (paracetamol), during the 7 days (or 5 half-lives, whichever is longer) before the first dose of study medication;
- Participation in another clinical study of a new chemical entity, new device, or a prescription medicine within the 3 months before dosing, or participation within 5 half-lives of receiving an experimental drug (whichever is longer);
- Presence or history of drug or alcohol abuse, or intake of more than 21 units (14 units for women) of alcohol weekly;
- Use of a prohibited therapy;
- Current smoker; or ex-smokers who (a) gave up less than 1 year ago, or (b) who had a history of more than 10 pack-years; Pack-years = cigarettes per day x number of years smoked/20
- Blood pressure and heart rate at the screening examination outside the ranges 90 150 mmHg systolic, 40-90 mmHg diastolic; heart rate 40-100 bpm;
- Loss of more than 400 mL blood, e.g. as a blood donor, or donation of blood products, during the 3 months before the study;
- History of tuberculosis infection;
- Receipt of a living vaccine within the 3 months before dosing;
- Active or latent parasitic infection, visit to a country with a high prevalence of parasitic infections within 3 months before receiving study medication;
- Positive faecal blood test at screening;
- Employee of the Investigator or the Sponsor, who was directly involved in the study, or a first-degree relative of such person;
Trial locations and contacts
1 site in 1 country.
Belgium1 site
SGS Life Sciences, Clinical Pharmacology Unit Antwerpen
Antwerp, 2020
About this study
Official title: Phase 1 Single Dose Escalation/Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, And Pharmacokinetics of Ascending Doses of a MEK Inhibitor (ATR-002) Given for 7 Days in Healthy Subjects
This was a combination of a single ascending dose (SAD) study to evaluate the safety, tolerability, and PK of 3 oral doses of a MEK inhibitor and a multiple ascending dose (MAD) study of 3 oral doses of a MEK inhibitor.
Subjects were to be enrolled in 3 different cohorts in the SAD and 3 different cohorts in the MAD and were to be randomly (blinded) allocated to active treatment or placebo (each cohort consisted of 8 subjects receiving active treatment and 2 subjects receiving placebo).
Read the detailed description
Each subject in the SAD cohorts was to receive a single dose of the MEK inhibitor ATR-002 (PD0184264), with a starting dose of 100 mg ATR-002 or placebo:
- Cohort 1: 100 mg ATR-002 or placebo;
- Cohort 2: 100 mg + X mg ATR-002 or placebo;
- Cohort 3: 100 mg + X mg + Y mg ATR-002 or placebo. An additional cohort (Cohort 4) of 10 subjects (4:1 active vs placebo) could have been recruited into the SAD Part, if appropriate.
Effectively, 4 cohorts were treated:
- Cohort 1: 100 mg ATR-002 or placebo;
- Cohort 2: 300 mg ATR-002 or placebo;
- Cohort 3: 600 mg ATR-002 or placebo;
- Cohort 4: 900 mg ATR-002 or placebo. Between each cohort, a blinded interim analysis of PK, safety and tolerability had to be performed. The available data was evaluated by the Investigator and sponsor in a Safety Review Committee (SRC) meeting.
Once a dose level was judged to be safe, the SRC determined the dose level for the next cohort considering a maximal increment of 400 mg compared to the previous cohort, and the next dose level could be administered to the next cohort.
The maximal dose level could not exceed 900 mg ATR-002. Each subject in the MAD cohorts was to receive once daily (QD) doses (fasted) of the MEK inhibitor ATR-002 for 7 days, starting with a dose of 100 mg ATR-002 or placebo QD.
- Cohort 5: 100 mg ATR-002 QD or placebo;
- Cohort 6: 100 mg + A mg ATR-002 QD or placebo;
- Cohort 7: 100 mg + A mg + B mg ATR-002 QD or placebo. An additional cohort (Cohort 8) of 10 subjects (4:1 active vs placebo) could be recruited into the MAD Part, if appropriate.
Effectively, 3 cohorts were treated:
- Cohort 5: 100 mg ATR-002 QD or placebo;
- Cohort 6: 300 mg ATR-002 QD or placebo;
- Cohort 7: 600 mg ATR-002 QD or placebo. Between each cohort, a blinded interim analysis of PK, safety and tolerability had to be performed. The available data was evaluated by the Investigator and sponsor in a SRC meeting. Once a dose level was judged to be safe, the SCR determined the dose level for the next cohort considering a maximal increment of 400 mg compared to the previous cohort, and the next dose level could be administered to the next cohort.
The maximal dose level could not exceed 900 mg ATR-002. During the study, no repeated daily dose could exceed the maximum single dose that has been shown to cause no safety concerns.
Subjects were resident on the ward from the day (late afternoon/evening) before dosing (Day -1) until completion of procedures at 96h following their final dose of study medication. They were to attend a follow up visit 28 days (± 2 days) following their final dose of study medication.
Subjects with AEs that were ongoing at the end of the study were followed up as appropriate until the AEs had resolved or stabilised, up to a maximum of 30 days after the last dose of study drug.
Pharmacokinetics were determined predose 30 min, 1h, 2h, 4h, 8h, 12h, and 24h, postdose, and predose on Day 2-4 in the SAD Part, and predose 30 min, 1h, 2h, 4h, 8h, 12h, and 24h, of Day 1 and Day 7, predose on Day 2-6 and 48h, 72h, and 96h post final dose of Day 7 in the MAD Part. The 72h and 96h samples in both SAD and MAD were only to be analysed if deemed informative based on the results of the 48h PK sample.
- Conditions
- Influenza
- Being tested
- ATR-002 MEK Inhibitor, Placebo oral tablet
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATR-002 MEK InhibitorDrug
Also called PD01842649
Drug ATR-002 administered as film-coated tablet via oral route
Placebo oral tabletDrug
Placebo film-coated tablet administered via oral route
| Study group | Role | What they receive |
|---|---|---|
| ATR-002 100 mg (SAD) | Experimental | 100 mg ATR-002 once (morning) Receives: Drug: ATR-002 MEK Inhibitor |
| ATR-002 300 mg (SAD) | Experimental | 300 mg ATR-002 once (morning) Receives: Drug: ATR-002 MEK Inhibitor |
| ATR-002 600 mg (SAD) | Experimental | 600 mg ATR-002 once (morning) Receives: Drug: ATR-002 MEK Inhibitor |
| ATR-002 900 mg (SAD) | Experimental | 900 mg ATR-002 once (morning) Receives: Drug: ATR-002 MEK Inhibitor |
| Placebo (SAD) | Placebo comparator | Placebo once (morning) Receives: Drug: Placebo oral tablet |
| ATR-002 100 mg (MAD) | Experimental | 100 mg ATR-002 once daily (morning) for 7 days Receives: Drug: ATR-002 MEK Inhibitor |
| ATR-002 300 mg (MAD) | Experimental | 300 mg ATR-002 once daily (morning) for 7 days Receives: Drug: ATR-002 MEK Inhibitor |
| ATR-002 600 mg (MAD) | Experimental | 600 mg ATR-002 once daily (morning) for 7 days Receives: Drug: ATR-002 MEK Inhibitor |
| Placebo (MAD) | Placebo comparator | Placebo once daily (morning) for 7 days Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events (TEAE) - SAD
TEAEs in SAD groups
Measured: Day 1- Day 5
Treatment-emergent adverse events (TEAE) - MAD
TEAEs in MAD groups
Measured: Day 1 - Day 11
Secondary outcomes (15)
Maximum plasma concentration - Cmax (SAD)
Cmax in SAD groups
Measured: Day 1- Day 5
Time to maximum plasma concentration tmax (SAD)
Tmax in SAD groups
Measured: Day 1- Day 5
Area under plasma concentration AUC0-t (SAD)
AUC0-t in SAD groups
Measured: Day 1- Day 5
Area under plasma concentration AUC0-inf (SAD)
AUC0-inf in SAD groups
Measured: Day 1- Day 5
Elimination half-life t1/2 (SAD)
t1/2 in SAD groups
Measured: Day 1- Day 5
Maximum plasma concentration - Cmax (MAD)
Cmax in MAD groups
Measured: Day 1 - Day 11
Time to maximum plasma concentration tmax (MAD)
Tmax in MAD groups
Measured: Day 1 - Day 11
Area under plasma concentration AUC0-t (MAD)
AUC0-t in MAD groups
Measured: Day 1 - Day 11
Area under plasma concentration AUC0-tau (MAD)
AUC0-tau in MAD groups
Measured: Day 1 - Day 11
Minimum plasma concentration Ctrough (MAD)
Ctrough in MAD groups
Measured: Day 1 - Day 11
Area under plasma concentration AUC0-inf (MAD)
AUC0-inf in MAD groups
Measured: Day 1 - Day 11
Elimination half-life t1/2 (MAD)
T1/2 in MAD groups
Measured: Day 1 - Day 11
Accumulation ratio Cmax (MAD)
Cmax Accumulation in MAD groups
Measured: Day 1 - Day 11
Accumulation ratio AUC0-tau (MAD)
AUC0-tau accumulation ratio in MAD groups
Measured: Day 1 - Day 11
Accumulation ratio Ctrough (MAD)
Ctrough accumulation ratio in MAD groups
Measured: Day 1 - Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start24 Apr 2019
- Primary completion26 Aug 2019
- Study completion26 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a combination of a single ascending dose (SAD) study to evaluate the safety, tolerability, and PK of 3 oral doses of a MEK inhibitor and a multiple ascending dose (MAD) study of 3 oral doses of a MEK inhibitor. Subjects were to be enrolled in 3 different cohorts in the SAD and 3 different cohorts in the MAD and were to be randomly (blinded) allocated to active treatment or placebo (each cohort consisted of 8 subjects receiving active treatment and 2 subjects receiving placebo).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atriva Therapeutics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SGS Life Sciences, a division of SGS Belgium NV
- Responsible party
- Sponsor
- Investigators
- Bram Volckaert, MD, Principal investigator, SGS Belgium NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385420
- Sponsor's protocol ID
- ATR002-01
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Single Dose Escalation/Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, And Pharmacokinetics of Ascending Doses of a MEK Inhibitor (ATR-002) Given for 7 Days in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04385420
- Acronym / sponsor ID
- ATR002-01
- Conditions
- Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Atriva Therapeutics GmbHIndustry (pharma, biotech, devices)
- Collaborators
- SGS Life Sciences, a division of SGS Belgium NV
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 26 Aug 2019 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 12 May 2020 (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 was a combination of a single ascending dose (SAD) study to evaluate the safety, tolerability, and PK of 3 oral doses of a MEK inhibitor and a multiple ascending dose (MAD) study of 3 oral doses of a MEK inhibitor.
Subjects were to be enrolled in 3 different cohorts in the SAD and 3 different cohorts in the MAD and were to be randomly (blinded) allocated to active treatment or placebo (each cohort consisted of 8 subjects receiving active treatment and 2 subjects receiving placebo).
Detailed description
Each subject in the SAD cohorts was to receive a single dose of the MEK inhibitor ATR-002 (PD0184264), with a starting dose of 100 mg ATR-002 or placebo:
- Cohort 1: 100 mg ATR-002 or placebo;
- Cohort 2: 100 mg + X mg ATR-002 or placebo;
- Cohort 3: 100 mg + X mg + Y mg ATR-002 or placebo. An additional cohort (Cohort 4) of 10 subjects (4:1 active vs placebo) could have been recruited into the SAD Part, if appropriate.
Effectively, 4 cohorts were treated:
- Cohort 1: 100 mg ATR-002 or placebo;
- Cohort 2: 300 mg ATR-002 or placebo;
- Cohort 3: 600 mg ATR-002 or placebo;
- Cohort 4: 900 mg ATR-002 or placebo. Between each cohort, a blinded interim analysis of PK, safety and tolerability had to be performed. The available data was evaluated by the Investigator and sponsor in a Safety Review Committee (SRC) meeting.
Once a dose level was judged to be safe, the SRC determined the dose level for the next cohort considering a maximal increment of 400 mg compared to the previous cohort, and the next dose level could be administered to the next cohort.
The maximal dose level could not exceed 900 mg ATR-002. Each subject in the MAD cohorts was to receive once daily (QD) doses (fasted) of the MEK inhibitor ATR-002 for 7 days, starting with a dose of 100 mg ATR-002 or placebo QD.
- Cohort 5: 100 mg ATR-002 QD or placebo;
- Cohort 6: 100 mg + A mg ATR-002 QD or placebo;
- Cohort 7: 100 mg + A mg + B mg ATR-002 QD or placebo. An additional cohort (Cohort 8) of 10 subjects (4:1 active vs placebo) could be recruited into the MAD Part, if appropriate.
Effectively, 3 cohorts were treated:
- Cohort 5: 100 mg ATR-002 QD or placebo;
- Cohort 6: 300 mg ATR-002 QD or placebo;
- Cohort 7: 600 mg ATR-002 QD or placebo. Between each cohort, a blinded interim analysis of PK, safety and tolerability had to be performed. The available data was evaluated by the Investigator and sponsor in a SRC meeting. Once a dose level was judged to be safe, the SCR determined the dose level for the next cohort considering a maximal increment of 400 mg compared to the previous cohort, and the next dose level could be administered to the next cohort.
The maximal dose level could not exceed 900 mg ATR-002. During the study, no repeated daily dose could exceed the maximum single dose that has been shown to cause no safety concerns.
Subjects were resident on the ward from the day (late afternoon/evening) before dosing (Day -1) until completion of procedures at 96h following their final dose of study medication. They were to attend a follow up visit 28 days (± 2 days) following their final dose of study medication.
Subjects with AEs that were ongoing at the end of the study were followed up as appropriate until the AEs had resolved or stabilised, up to a maximum of 30 days after the last dose of study drug.
Pharmacokinetics were determined predose 30 min, 1h, 2h, 4h, 8h, 12h, and 24h, postdose, and predose on Day 2-4 in the SAD Part, and predose 30 min, 1h, 2h, 4h, 8h, 12h, and 24h, of Day 1 and Day 7, predose on Day 2-6 and 48h, 72h, and 96h post final dose of Day 7 in the MAD Part. The 72h and 96h samples in both SAD and MAD were only to be analysed if deemed informative based on the results of the 48h PK sample.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
- Model description
- This was a combination of a single ascending dose (SAD) study to evaluate the safety, tolerability, and PK of 3 oral doses of a MEK inhibitor and a multiple ascending dose (MAD) study of 3 oral doses of a MEK inhibitor. Subjects were to be enrolled in 3 different cohorts in the SAD and 3 different cohorts in the MAD and were to be randomly (blinded) allocated to active treatment or placebo (each cohort consisted of 8 subjects receiving active treatment and 2 subjects receiving placebo).
| Arm | Type | Receives |
|---|---|---|
| ATR-002 100 mg (SAD) | Experimental | Drug: ATR-002 MEK Inhibitor100 mg ATR-002 once (morning) |
| ATR-002 300 mg (SAD) | Experimental | Drug: ATR-002 MEK Inhibitor300 mg ATR-002 once (morning) |
| ATR-002 600 mg (SAD) | Experimental | Drug: ATR-002 MEK Inhibitor600 mg ATR-002 once (morning) |
| ATR-002 900 mg (SAD) | Experimental | Drug: ATR-002 MEK Inhibitor900 mg ATR-002 once (morning) |
| Placebo (SAD) | Placebo comparator | Drug: Placebo oral tabletPlacebo once (morning) |
| ATR-002 100 mg (MAD) | Experimental | Drug: ATR-002 MEK Inhibitor100 mg ATR-002 once daily (morning) for 7 days |
| ATR-002 300 mg (MAD) | Experimental | Drug: ATR-002 MEK Inhibitor300 mg ATR-002 once daily (morning) for 7 days |
| ATR-002 600 mg (MAD) | Experimental | Drug: ATR-002 MEK Inhibitor600 mg ATR-002 once daily (morning) for 7 days |
| Placebo (MAD) | Placebo comparator | Drug: Placebo oral tabletPlacebo once daily (morning) for 7 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Male or female, between 18 and 55 years old, extremes included;
- Weighed at least 50 kg and had a body mass index (BMI) within normal range: 18.0≤ BMI <31.0 kg/m2;
- In good physical and mental health as determined on the basis of medical history and general physical examination performed at screening;
- Haematology and chemistry parameters, pulse rate and/or blood pressure, and ECG within the reference range for the population studied, or showing no clinically relevant deviations, as judged by the Investigator;
- Negative urine test for selected drugs of abuse at screening and upon check-in at the clinical site; Note: Subjects could not consume poppy-seeds within 24h before screening and before each urine drug screening because this could falsify the results of the opiate urine drug test.
Key exclusion criteria (19 listed)
- Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-study screening assessment that could interfere with the objectives of the study or the safety of the subject;
- Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the subject's participation in the study or make it unnecessarily hazardous;
- A condition that, in the opinion of the Investigator, could compromise the well being of the subject or course of the study, or prevent the subject from meeting or performing any study requirements;
- Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, cancer, or history of any psychotic mental illness;
- Respiratory tract infection within 4 weeks before the screening visit;
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 |
|---|---|---|
| ATR-002 MEK InhibitorAlso: PD01842649Drug ATR-002 administered as film-coated tablet via oral route | Drug | ATR-002 100 mg (MAD), ATR-002 100 mg (SAD), ATR-002 300 mg (MAD), ATR-002 300 mg (SAD), ATR-002 600 mg (MAD), ATR-002 600 mg (SAD), ATR-002 900 mg (SAD) |
| Placebo oral tabletPlacebo film-coated tablet administered via oral route | Drug | Placebo (MAD), Placebo (SAD) |
Primary outcome
Treatment-emergent adverse events (TEAE) - SAD
Time frame: Day 1- Day 5
TEAEs in SAD groups
Treatment-emergent adverse events (TEAE) - MAD
Time frame: Day 1 - Day 11
TEAEs in MAD groups
15 secondary outcomes
Maximum plasma concentration - Cmax (SAD)
Time frame: Day 1- Day 5
Time to maximum plasma concentration tmax (SAD)
Time frame: Day 1- Day 5
Area under plasma concentration AUC0-t (SAD)
Time frame: Day 1- Day 5
Area under plasma concentration AUC0-inf (SAD)
Time frame: Day 1- Day 5
Elimination half-life t1/2 (SAD)
Time frame: Day 1- Day 5
Maximum plasma concentration - Cmax (MAD)
Time frame: Day 1 - Day 11
Time to maximum plasma concentration tmax (MAD)
Time frame: Day 1 - Day 11
Area under plasma concentration AUC0-t (MAD)
Time frame: Day 1 - Day 11
Area under plasma concentration AUC0-tau (MAD)
Time frame: Day 1 - Day 11
Minimum plasma concentration Ctrough (MAD)
Time frame: Day 1 - Day 11
Area under plasma concentration AUC0-inf (MAD)
Time frame: Day 1 - Day 11
Elimination half-life t1/2 (MAD)
Time frame: Day 1 - Day 11
Accumulation ratio Cmax (MAD)
Time frame: Day 1 - Day 11
Accumulation ratio AUC0-tau (MAD)
Time frame: Day 1 - Day 11
Accumulation ratio Ctrough (MAD)
Time frame: Day 1 - Day 11
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 13 May 2020.
- 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.
Bram Volckaert, MD principal investigator
SGS Belgium NV
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 ATR-002 MEK Inhibitor in people with Influenza, run by Atriva Therapeutics GmbH at 1 site in Belgium.
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 15 inclusion and 19 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 13 May 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
Treatment-emergent adverse events (TEAE) - SAD (time frame: Day 1- Day 5). 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 13 May 2020.