Health TrialsbyHealthPanel

Study of the Safety, Tolerability, and Pharmacokinetic Profile of Ascending Doses of Ingavirin Forte, Capsules, Folliwing Single and Subsequent Multiple Oral Administration in Healthy Volunteers

ConditionsInfluenzaViral Respiratory Infection
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorValenta Pharm JSC

About this trial

This is a Single Center, First-in-human Study of Safety, Tolerability, and Pharmacokinetic Profile of Ascending Single and Multiple Doses of Ingavirin Forte, Capsules in Healthy Volunteers.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Signed informed consent form by the healthy subject prior to any study activities.

Males and females aged 18 to 45 years (inclusive) of Caucasian race.

Verified "healthy" diagnosis (no abnormalities detected based on clinical, laboratory, and instrumental examination methods specified in the protocol).

Blood pressure (BP) levels: systolic blood pressure (SBP) from 100 to 130 mm Hg (inclusive), diastolic blood pressure (DBP) from 70 to 85 mm Hg (inclusive).

Disqualifiers

The volunteer's withdrawal from further participation in the study.

Non-compliance by the volunteer with the study participation rules (missed study procedures, self-administration of prohibited medications, violation of dietary and lifestyle restrictions, etc.).

The emergence of reasons/situations during the study that threaten the safety of the volunteer (e.g., hypersensitivity reactions, etc.).

Volunteers selected for participation in the study who do not meet inclusion/exclusion criteria.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Combined preparation of imidazolylethylamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid, 90 mg + 5 mg

    Drug

    Capsules, containing 90 mg of imidazolylethylamide of pentanedioic acid and 5 mg of N,N'-bis-\[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl\] diamide of malonic acid

  • Combined preparation of imidazolylethylamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid, 90 mg + 10 mg

    Drug

    Capsules, containing 90 mg of imidazolylethylamide of pentanedioic acid and 10 mg of N,N'-bis-\[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl\] diamide of malonic acid

  • Combined preparation of imidazolylethylamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid, 90 mg + 20 mg

    Drug

    Capsules, containing 90 mg of imidazolylethylamide of pentanedioic acid and 20 mg of N,N'-bis-\[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl\] diamide of malonic acid

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: Single and multiple doses, 90 mg + 5 mgExperimental treatment 1 intervention
Group B: Single and multiple doses, 90 mg + 10 mgExperimental treatment 1 intervention
Group C: Single and multiple doses, 90 mg + 20 mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pharmacokinetics - Cmax

Maximum plasma concentration (Cmax) of imidazolylethylamide of pentanedioic acid and N,N'-bis-\[2-(1,3-diazocyclopent-2,4-dien-4-yl)ethyl\] diamide of malonic acid. The same analytes would be used for other pharmacokinetic measures listed below.

Time frame
From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)
2

Pharmacokinetics - tmax

Time to reach Cmax (tmax)

Time frame
From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)
3

Pharmacokinetics - AUC0-t

Area under the plasma concentration-time curve from time 0 to t (AUC0-t)

Time frame
From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)
4

Pharmacokinetics - AUC0-inf

Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)

Time frame
From 0 hours extrapolated to infinity after single dose and from 48 hours extrapolated to infinity after multiple dose

Secondary outcomes

1

Adverse event type

Adverse events will be assessed by complaints, results of physical examination, results of heart rate and blood pressure assessment, results of respiratory rate assessment, body temperature, laboratory monitoring (clinical blood count, biochemical blood count, urinalysis), electrocardiography; adverse events will be classified in accordance to MedDRA.

Time frame
From Day -14 to Day -1 (screening), from Day 1 to Day 21 (single dosing and subsequent wash-out period), from Day 1 to Day 11 (multiple dosing and subsequent observation period)
2

Adverse event number

Number of adverse events registered during the study

Time frame
From Day -14 to Day -1 (screening), from Day 1 to Day 21 (single dosing and subsequent wash-out period), from Day 1 to Day 11 (multiple dosing and subsequent observation period)
3

Adverse event severety

Severity of adverse events registered during the study

Time frame
From Day -14 to Day -1 (screening), from Day 1 to Day 21 (single dosing and subsequent wash-out period), from Day 1 to Day 11 (multiple dosing and subsequent observation period)
4

Drop-outs associated with adverse events

The number of cases of early termination of participation in the study due to the development of adverse events and/or serious adverse events associated with the study drug

Time frame
From Day -14 to Day -1 (screening), from Day 1 to Day 21 (single dosing and subsequent wash-out period), from Day 1 to Day 11 (multiple dosing and subsequent observation period)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Valenta Pharm JSC

Lead sponsor

Source ClinicalTrials.gov
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