InfluenzaPhase 1NCT03459391

Study to Assess Safety, Tolerability and Pharmacokinetics of XC221 in Healthy Volunteers

A Phase 1 study testing XC221 60 mg and XC221 200 mg in people with Influenza and Acute Respiratory Infection, run by PHARMENTERPRISES LLC at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Influenza, Acute Respiratory Infection
What is being tested?: XC221 60 mg and XC221 200 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteRussia
Study dates: 22 May 2017to 26 Sep 2017
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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Non-smoking men aged 18 to 45 years (inclusive);
Verified diagnosis "healthy" according to standard clinical, laboratory and instrumental methods of examination;
Body mass >50 kg and body mass index of 18.5 to 30 kg/m2 (inclusive);
Negative result of tests for alcohol and drugs;
Consent to use reliable methods of contraception during the study and 3 months after its completion (condoms with spermicide);
Signed patient information sheet and informed consent form for participation in the study.

Who cannot join

Chronic diseases of cardiovascular, bronchopulmonary, neuroendocrine, musculoskeletal system and also disease of digestive tract, liver, kidneys, blood;
Laboratory abnormalities at screening;
Surgical interventions on digestive tract in the anamnesis (except for an appendectomies);
Systolic pressure is less than 90 mm Hg. or more than 130 mm Hg., diastolic pressure is less than 60 mm Hg. or more than 85 mm Hg., pulse rate less than 60/min. or more than 80/min.;
Course intake of medicinal products (including herbs and biologically active additives) for preventive or curative purposes within 1 month prior to screening;
Antibodies to HIV and hepatitis C virus, the presence of the hepatitis B surface antigen, a positive syphilis test;

Show all 13Show fewer

The presence of a sleep disorder (for example, night work, sleep disturbances, insomnia, recent return from another time zone, etc.);
Signs of alcohol or drug abuse; taking alcohol or drugs during 4 days before screening; smoking 3 months before screening;
History of allergies (including medicines and food products);
Blood donation / plasma, surgical intervention (in a hospital environment) during 12 weeks before screening;
Participation in other clinical trials or taking the study drug during 3 months before screening;
Acute infectious diseases less than 4 weeks before the start of the study;
Impossibility to understand or follow protocol instructions/

Trial locations and contacts

1 site in 1 country.

Russia1 site

SBEI HPE The First Moscow State Medical University n.a. Sechenov of Ministry of Health of Russian Federation, University Hospital #2, Department of Development of New Medicines
Moscow, 119435

Other trials in Russia

About this study

Official title: A Double-blind, Randomized, Placebo-controlled Study of the Safety,Tolerability and Pharmacokinetics of Increasing Doses of XC221 After Single and Repeated Oral Administration in Healthy Volunteers

A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety and tolerability of increasing doses of drug XC221 after single and repeated oral administration in healthy volunteers. The volunteers received the study drug once, and then continued daily intake for 5 days after a 6-day break. The primary objective of the study was to evaluate the safety and tolerability profile for drug XC221 after single and multiple administration based on the frequency and severity of adverse events and changes in vital signs, laboratory results, electrocardiography and results of the physical examination. The secondary objective of the study was to assess pharmacokinetics of active pharmaceutical substance XC221GI and its metabolite XC221A.

Read the detailed description

One Russian center was approved for participation in this study. One center was initiated. Healthy volunteers were enrolled in 1 center. The study consisted of 4 periods: screening, single administration, multiple administration and follow-up.

All eligible subjects were randomized into the study in appropriate cohort groups sequentially. Cohort 1 - XC221 or Placebo 60 mg once and then daily 5 days after a 6-day break; Cohort 2 - XC221 or Placebo 200 mg once and then daily during 5 days after a 6-day break. The decision regarding increasing of the study drug dose for a subsequent cohort was made by the Data Safety Monitoring Committee on the basis of preliminary safety results assessment. A total of 24 volunteers received XC221 (60 mg or 200 mg) and a total of 8 volunteers received the placebo during the study participation. The follow-up period lasted for 4 weeks.

Conditions: Influenza, Acute Respiratory Infection
Being tested: XC221 60 mg, XC221 200 mg, Placebo
Keywords: Healthy volunteers, Phase I, PHARMENTERPRISES
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

XC221 60 mgDrug
The volunteers received the study drug once, and then continued daily intake for 5 days after a 6-day break.
XC221 200 mgDrug
The volunteers received the study drug once, and then continued daily intake for 5 days after a 6-day break.
PlaceboDrug
The volunteers received the study drug once, and then continued daily intake for 5 days after a 6-day break.

Study groups in NCT03459391
Study group	Role	What they receive
XC221 60 mg	Experimental	Cohort 1:16 subjects were randomized in a 3:1 ratio to be treated either with 60 mg XC221 (12 subjects) or placebo (4 subjects, see placebo arm). Receives: Drug: XC221 60 mg
XC221 200 mg	Experimental	Cohort 2: 16 subjects were randomized in a 3:1 ratio to be treated either with 200 mg XC221 (12 subjects) or placebo (4 subjects, see placebo arm). Receives: Drug: XC221 200 mg
Placebo	Placebo comparator	Placebo comparator arm consists of 8 subjects (4 subjects from each cohort). Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Adverse events per treatment arm
Adverse events have been classified according to CTCAE ver 4.03. Adverse events will be summarized descriptively by treatment arm. Verbatim terms will be mapped to preferred terms and organ systems using the current Medical Dictionary for Regulatory Activities version. For each preferred term, frequency counts and percentages will be calculated by cohort.The nature, severity, seriousness, and relationship to study medication will be summarized for all study subjects
Measured: Change from pre-dose to Day 28

Secondary outcomes (10)

Pharmacokinetics of XC221GI by assessing AUC0-inf
Area under the curve "concentration of the drug-time" from the time of administration of the drug till infinity
Measured: Day 1 and 11 (Pre dose, 15 min, 30 min, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8,12 and 16 h post dose), Day 2 and Day 12 (24 h ±10 min post dose), Day 3 and Day 13 (48 h ±10 min post dose), Day 4 and Day 14 (72 h ±10 min post dose), Day 7 to 10 (Pre dose)
Pharmacokinetics of XC221A by assessing AUC0-inf
Area under the curve "concentration of the drug-time" from the time of administration of the drug till infinity
Measured: Day 1 and 11 (Pre dose, 15 min, 30 min, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8,12 and 16 h post dose), Day 2 and Day 12 (24 h ±10 min post dose), Day 3 and Day 13 (48 h ±10 min post dose), Day 4 and Day 14 (72 h ±10 min post dose), Day 7 to 10 (Pre dose)
Pharmacokinetics of XC221GI by assessing Cmax
Maximum plasma concentration
Measured: Day 1 and 11 (Pre dose, 15 min, 30 min, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8,12 and 16 h post dose), Day 2 and Day 12 (24 h ±10 min post dose), Day 3 and Day 13 (48 h ±10 min post dose), Day 4 and Day 14 (72 h ±10 min post dose), Day 7 to 10 (Pre dose)
Pharmacokinetics of XC221A by assessing Cmax
Maximum plasma concentration
Measured: Day 1 and 11 (Pre dose, 15 min, 30 min, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8,12 and 16 h post dose), Day 2 and Day 12 (24 h ±10 min post dose), Day 3 and Day 13 (48 h ±10 min post dose), Day 4 and Day 14 (72 h ±10 min post dose), Day 7 to 10 (Pre dose)
Pharmacokinetics of XC221GI by assessing AUC0-t
Area under the curve "concentration of the drug-time" from the time of administration of the drug till the time (t) the last blood sampling
Measured: Day 1 and 11 (Pre dose, 15 min, 30 min, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8,12 and 16 h post dose), Day 2 and Day 12 (24 h ±10 min post dose), Day 3 and Day 13 (48 h ±10 min post dose), Day 4 and Day 14 (72 h ±10 min post dose), Day 7 to 10 (Pre dose)
Pharmacokinetics of XC221A by assessing AUC0-t
Area under the curve "concentration of the drug-time" from the time of administration of the drug till the time (t) the last blood sampling
Measured: Day 1 and 11 (Pre dose, 15 min, 30 min, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8,12 and 16 h post dose), Day 2 and Day 12 (24 h ±10 min post dose), Day 3 and Day 13 (48 h ±10 min post dose), Day 4 and Day 14 (72 h ±10 min post dose), Day 7 to 10 (Pre dose)
Pharmacokinetics of XC221GI by assessing Tmax
Time to maximum drug concentration in the blood plasma administration
Measured: Day 1 and 11 (Pre dose, 15 min, 30 min, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8,12 and 16 h post dose), Day 2 and Day 12 (24 h ±10 min post dose), Day 3 and Day 13 (48 h ±10 min post dose), Day 4 and Day 14 (72 h ±10 min post dose), Day 7 to 10 (Pre dose)
Pharmacokinetics of XC221A by assessing Tmax
Time to maximum drug concentration in the blood plasma administration
Measured: Day 1 and 11 (Pre dose, 15 min, 30 min, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8,12 and 16 h post dose), Day 2 and Day 12 (24 h ±10 min post dose), Day 3 and Day 13 (48 h ±10 min post dose), Day 4 and Day 14 (72 h ±10 min post dose), Day 7 to 10 (Pre dose)
Pharmacokinetics of XC221GI by assessing T1/2
Terminal elimination half-life
Measured: Day 1 and 11 (Pre dose, 15 min, 30 min, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8,12 and 16 h post dose), Day 2 and Day 12 (24 h ±10 min post dose), Day 3 and Day 13 (48 h ±10 min post dose), Day 4 and Day 14 (72 h ±10 min post dose), Day 7 to 10 (Pre dose)
Pharmacokinetics of XC221A by assessing T1/2
Terminal elimination half-life
Measured: Day 1 and 11 (Pre dose, 15 min, 30 min, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8,12 and 16 h post dose), Day 2 and Day 12 (24 h ±10 min post dose), Day 3 and Day 13 (48 h ±10 min post dose), Day 4 and Day 14 (72 h ±10 min post dose), Day 7 to 10 (Pre dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 May 201726 Sep 2017

First posted8 Mar 2018
Study start22 May 2017
Primary completion26 Sep 2017
Study completion26 Sep 2017

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: Sequential
Model description: The dose cohorts were included into the study subsequently based on preliminary safety results evaluation performed by the Data Safety Monitoring Committee. 2 doses of XC221/placebo (60 mg and 200 mg) were used in the study.The duration of exposure to the study drug was 6 days in each cohort: Day 1, once, at the step of single administration, and then in 6 days, daily, 1 time a day for 5 days at the step of multiple administration.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03459391
Sponsor's protocol ID: ARI-XC221-01
Status last verified: Mar 2018
First submitted: 26 Feb 2018
Last updated: 8 Mar 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomized, Placebo-controlled Study of the Safety,Tolerability and Pharmacokinetics of Increasing Doses of XC221 After Single and Repeated Oral Administration in Healthy Volunteers
ClinicalTrials.gov ID: NCT03459391
Acronym / sponsor ID: ARI-XC221-01
Conditions: Influenza, Acute Respiratory Infection
Keywords: Healthy volunteers, Phase I, PHARMENTERPRISES
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: PHARMENTERPRISES LLCIndustry (pharma, biotech, devices)
Study start: 22 May 2017 (actual)
Primary completion: 26 Sep 2017 (actual)
Study completion: 26 Sep 2017 (actual)
First posted: 8 Mar 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 3
Model description: The dose cohorts were included into the study subsequently based on preliminary safety results evaluation performed by the Data Safety Monitoring Committee. 2 doses of XC221/placebo (60 mg and 200 mg) were used in the study.The duration of exposure to the study drug was 6 days in each cohort: Day 1, once, at the step of single administration, and then in 6 days, daily, 1 time a day for 5 days at the step of multiple administration.

Arm	Type	Receives
XC221 60 mg	Experimental	Drug: XC221 60 mgCohort 1:16 subjects were randomized in a 3:1 ratio to be treated either with 60 mg XC221 (12 subjects) or placebo (4 subjects, see placebo arm).
XC221 200 mg	Experimental	Drug: XC221 200 mgCohort 2: 16 subjects were randomized in a 3:1 ratio to be treated either with 200 mg XC221 (12 subjects) or placebo (4 subjects, see placebo arm).
Placebo	Placebo comparator	Drug: PlaceboPlacebo comparator arm consists of 8 subjects (4 subjects from each cohort).

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Non-smoking men aged 18 to 45 years (inclusive);
Verified diagnosis "healthy" according to standard clinical, laboratory and instrumental methods of examination;
Body mass >50 kg and body mass index of 18.5 to 30 kg/m2 (inclusive);
Negative result of tests for alcohol and drugs;
Consent to use reliable methods of contraception during the study and 3 months after its completion (condoms with spermicide);

Key exclusion criteria (13 listed)

Chronic diseases of cardiovascular, bronchopulmonary, neuroendocrine, musculoskeletal system and also disease of digestive tract, liver, kidneys, blood;
Laboratory abnormalities at screening;
Surgical interventions on digestive tract in the anamnesis (except for an appendectomies);
Systolic pressure is less than 90 mm Hg. or more than 130 mm Hg., diastolic pressure is less than 60 mm Hg. or more than 85 mm Hg., pulse rate less than 60/min. or more than 80/min.;
Course intake of medicinal products (including herbs and biologically active additives) for preventive or curative purposes within 1 month prior to screening;

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
XC221 60 mgThe volunteers received the study drug once, and then continued daily intake for 5 days after a 6-day break.	Drug	XC221 60 mg
XC221 200 mgThe volunteers received the study drug once, and then continued daily intake for 5 days after a 6-day break.	Drug	XC221 200 mg
PlaceboThe volunteers received the study drug once, and then continued daily intake for 5 days after a 6-day break.	Drug	Placebo

Primary outcome

Number of Adverse events per treatment arm
Time frame: Change from pre-dose to Day 28
Adverse events have been classified according to CTCAE ver 4.03. Adverse events will be summarized descriptively by treatment arm. Verbatim terms will be mapped to preferred terms and organ systems using the current Medical Dictionary for Regulatory Activities version. For each preferred term, frequency counts and percentages will be calculated by cohort.The nature, severity, seriousness, and relationship to study medication will be summarized for all study subjects

10 secondary outcomes

Pharmacokinetics of XC221GI by assessing AUC0-inf
Time frame: Day 1 and 11 (Pre dose, 15 min, 30 min, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8,12 and 16 h post dose), Day 2 and Day 12 (24 h ±10 min post dose), Day 3 and Day 13 (48 h ±10 min post dose), Day 4 and Day 14 (72 h ±10 min post dose), Day 7 to 10 (Pre dose)
Pharmacokinetics of XC221A by assessing AUC0-inf
Time frame: Day 1 and 11 (Pre dose, 15 min, 30 min, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8,12 and 16 h post dose), Day 2 and Day 12 (24 h ±10 min post dose), Day 3 and Day 13 (48 h ±10 min post dose), Day 4 and Day 14 (72 h ±10 min post dose), Day 7 to 10 (Pre dose)
Pharmacokinetics of XC221GI by assessing Cmax
Time frame: Day 1 and 11 (Pre dose, 15 min, 30 min, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8,12 and 16 h post dose), Day 2 and Day 12 (24 h ±10 min post dose), Day 3 and Day 13 (48 h ±10 min post dose), Day 4 and Day 14 (72 h ±10 min post dose), Day 7 to 10 (Pre dose)
Pharmacokinetics of XC221A by assessing Cmax
Time frame: Day 1 and 11 (Pre dose, 15 min, 30 min, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8,12 and 16 h post dose), Day 2 and Day 12 (24 h ±10 min post dose), Day 3 and Day 13 (48 h ±10 min post dose), Day 4 and Day 14 (72 h ±10 min post dose), Day 7 to 10 (Pre dose)
Pharmacokinetics of XC221GI by assessing AUC0-t
Time frame: Day 1 and 11 (Pre dose, 15 min, 30 min, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8,12 and 16 h post dose), Day 2 and Day 12 (24 h ±10 min post dose), Day 3 and Day 13 (48 h ±10 min post dose), Day 4 and Day 14 (72 h ±10 min post dose), Day 7 to 10 (Pre dose)
Pharmacokinetics of XC221A by assessing AUC0-t
Time frame: Day 1 and 11 (Pre dose, 15 min, 30 min, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8,12 and 16 h post dose), Day 2 and Day 12 (24 h ±10 min post dose), Day 3 and Day 13 (48 h ±10 min post dose), Day 4 and Day 14 (72 h ±10 min post dose), Day 7 to 10 (Pre dose)
Pharmacokinetics of XC221GI by assessing Tmax
Time frame: Day 1 and 11 (Pre dose, 15 min, 30 min, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8,12 and 16 h post dose), Day 2 and Day 12 (24 h ±10 min post dose), Day 3 and Day 13 (48 h ±10 min post dose), Day 4 and Day 14 (72 h ±10 min post dose), Day 7 to 10 (Pre dose)
Pharmacokinetics of XC221A by assessing Tmax
Time frame: Day 1 and 11 (Pre dose, 15 min, 30 min, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8,12 and 16 h post dose), Day 2 and Day 12 (24 h ±10 min post dose), Day 3 and Day 13 (48 h ±10 min post dose), Day 4 and Day 14 (72 h ±10 min post dose), Day 7 to 10 (Pre dose)
Pharmacokinetics of XC221GI by assessing T1/2
Time frame: Day 1 and 11 (Pre dose, 15 min, 30 min, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8,12 and 16 h post dose), Day 2 and Day 12 (24 h ±10 min post dose), Day 3 and Day 13 (48 h ±10 min post dose), Day 4 and Day 14 (72 h ±10 min post dose), Day 7 to 10 (Pre dose)
Pharmacokinetics of XC221A by assessing T1/2
Time frame: Day 1 and 11 (Pre dose, 15 min, 30 min, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8,12 and 16 h post dose), Day 2 and Day 12 (24 h ±10 min post dose), Day 3 and Day 13 (48 h ±10 min post dose), Day 4 and Day 14 (72 h ±10 min post dose), Day 7 to 10 (Pre dose)

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 8 Mar 2018.
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.

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 XC221 60 mg and XC221 200 mg in people with Influenza and Acute Respiratory Infection, run by PHARMENTERPRISES LLC at 1 site in Russia.

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 6 inclusion and 13 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 8 Mar 2018. 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 Russia. 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?

Number of Adverse events per treatment arm (time frame: Change from pre-dose to Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03459391.

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 8 Mar 2018.