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CompletedNCT03459391Updated Mar 8, 2018

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

A Phase 1 interventional study of XC221 60 mg and XC221 200 mg in Influenza and Acute Respiratory Infection, sponsored by PHARMENTERPRISES LLC. Completed at 1 site in Russian Federation. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-08.

Sponsored by PHARMENTERPRISES LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Influenza
  • Acute Respiratory Infection

Keywords

  • Healthy volunteers
  • Phase I
  • PHARMENTERPRISES
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Chronic diseases of cardiovascular, bronchopulmonary, neuroendocrine, musculoskeletal system and also disease of digestive tract, liver, kidneys, blood;
  2. Laboratory abnormalities at screening;
  3. Surgical interventions on digestive tract in the anamnesis (except for an appendectomies);
  4. 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.;
  5. Course intake of medicinal products (including herbs and biologically active additives) for preventive or curative purposes within 1 month prior to screening;
  6. Antibodies to HIV and hepatitis C virus, the presence of the hepatitis B surface antigen, a positive syphilis test;
  7. The presence of a sleep disorder (for example, night work, sleep disturbances, insomnia, recent return from another time zone, etc.);
  8. Signs of alcohol or drug abuse; taking alcohol or drugs during 4 days before screening; smoking 3 months before screening;
  9. History of allergies (including medicines and food products);
  10. Blood donation / plasma, surgical intervention (in a hospital environment) during 12 weeks before screening;
  11. Participation in other clinical trials or taking the study drug during 3 months before screening;
  12. Acute infectious diseases less than 4 weeks before the start of the study;
  13. Impossibility to understand or follow protocol instructions/
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    XC221 60 mg

    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).

    Drug: XC221 60 mg

  • Experimental
    XC221 200 mg

    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).

    Drug: XC221 200 mg

  • Placebo comparator
    Placebo

    Placebo comparator arm consists of 8 subjects (4 subjects from each cohort).

    Drug: Placebo

Interventions

  • DrugXC221 60 mg

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

  • DrugXC221 200 mg

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

  • DrugPlacebo

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

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Change from pre-dose to Day 28

Secondary outcomes

  1. 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

    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)

  2. 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

    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)

  3. Pharmacokinetics of XC221GI by assessing Cmax

    Maximum plasma concentration

    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)

  4. Pharmacokinetics of XC221A by assessing Cmax

    Maximum plasma concentration

    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)

  5. 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

    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)

  6. 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

    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)

  7. Pharmacokinetics of XC221GI by assessing Tmax

    Time to maximum drug concentration in the blood plasma administration

    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)

  8. Pharmacokinetics of XC221A by assessing Tmax

    Time to maximum drug concentration in the blood plasma administration

    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)

  9. Pharmacokinetics of XC221GI by assessing T1/2

    Terminal elimination half-life

    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)

  10. Pharmacokinetics of XC221A by assessing T1/2

    Terminal elimination half-life

    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)

06

Study locations

1 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, Russian Federation
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03459391
Lead sponsor
PHARMENTERPRISES LLC
Responsible party
Sponsor
First posted
Mar 8, 2018
Start date
May 22, 2017
Primary completion
Sep 26, 2017
Completion
Sep 26, 2017
Last update
Mar 8, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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