SOFIA Study

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Pharmacodynamics and pharmacokinetics of two formulations containing a synergic mixture of interferons in healthy volunteers.

Secondary indentifying numbers:

IG/IAG/FD/1101

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB).

Source(s) of monetary or material support:

HeberBiotec S.A.

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Reference number:

05-008-11-B (Procedure code), May 18, 2011.

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Alina Díaz Machado MD.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

National Center for Toxicology, March 28, 2011.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

15/07/2011

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Pharmacodynamics and pharmacokinetics of interferon formulations in healthy volunteers.

Intervention(s):

A phase I, randomized, crossover (two period), double-blind study with a three-weeks washout period as minimum will be carried out in healthy volunteers. Formulation A (Control): Interferon alpha 2b and interferon gamma (HeberPAG) Formulation B: interferon alpha 2b and interferon gamma (New Formulation) - A single 24.5 x 106 IU will be administered intramuscularly in both groups. - The study will last 192 hours (9 days) in each treatment period. - During each period, individuals were hospitalized during the first 48 hours after the injection under strict medical supervision. - Blood sampling and adverse reactions monitoring will be continued ambulatorily until 192 hours. - Antipyretic medication will be given orally at the same time as the IFN injection and up to 12 hours or more if needed, in order to mitigate the expected IFN-dependent flu-like syndrome.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Pharmacodynamics measured by the following variables: - Serum neopterin levels (values expressed in ng/mL). Time measurement: Before and 6, 12, 24, 48, 72, 96, 120, 168 and 192 hours after injection at each treatment period. - Serum?ß2-microglobulin (ß2M) (values expressed in µg/mL). Time measurement: Before and 6, 12, 24, 48, 72, 96, 120, 168 and 192 hours after injection at each treatment period. - 2',5' oligoadenylate synthetase (2',5' OAS) mRNA expression in peripheral blood (RNA concentration). Time measurement: Before and 6, 12, 24, 48, 72, 96, 120, 168 and 192 hours after injection at each treatment period.

Key secondary outcomes:

Pharmacokinetics and clinical evaluation measures through the following variables: - Serum levels of interferon alpha and interferon gamma (values ??expressed pg/mL). Measuring time: at baseline and at 2, 3, 4, 6, 7, 8, 10, 12, 14, 16, 24, 36 and 48 hours after administration. - Vital signs (body temperature in degrees Celsius, heart rate in beats per minute, blood pressure in mm Hg and respiratory rate in breaths per minute). Measuring time: at baseline and at 2, 3, 4, 6, 7, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours in each period. - Determination of hematology and clinical chemistry (numerical values ??as measurement units for each determination). Measuring time: at baseline and at 24, 48, 72, 96, 120, 168 and 192 hours after administration of interferons, in each period.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male

Minimum age:

18 years

Maximum age:

35 years

Inclusion criteria:

1) Body mass index between 19 and 29 Kg/m2. 2) Hematological parameters (hemogram, globular sedimentation rate, coagulogram) within normal limits. 3) Biochemical parameters (glucose, cholesterol, creatinine, urea, uric acid, alkaline phospatase, transaminases, bilirubin, others) within normal limits. 4) Urine analysis (density, pH, glucose, bilis, leukocytes, erythrocytes) within normal limits. 5) No reactive serology and negative to HIV, hepatitis B and C virus infections markers in serum. 6) No consumption of drugs in the previous 15 days. 7) No symptoms or signs of any disease at the physical examination. 8) Written, informed consent to participate.

Exclusion criteria:

1) No fulfillment of any inclusion criteria. 2) History of chronic diseases. 3) Suffer any acute illness in the previous 30 days. 4) Smoking habit. 5) History of allergic reactions or hypersensibility to drugs (including antipyretics and interferons) and any ingredient of both studied formulations (considering investigator criteria) 6) Alcoholism (more than a quarter of rum bottle, one wine bottle or three beers, more than two times per week), or addiction to drugs in the previous year. 7) Surgical interventions in the previous 6 months. 8) Blood donation in the previous 2 months. 9) Treatment with any type of interferon at any moment previous inclusion. 10) To have been included in another clinical trial with therapeutic intervention in the previous year before inclusion.

Type of population:

Adults

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Other

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Active

Study design:

Crossover

Phase:

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

MSc. Idrian

Last Name:

García García

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 e/ 158 y 190, Cubanacán, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

idrian.garcia@cigb.edu.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Dr. Iraldo

Middle Name:

Jesús

Last Name:

Bello Rivero

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

iraldo.bello@cigb.edu.cu [3]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000118

Date of Registration in Primary Registry:

2011-05-24

Record Verification Date:

2011-05-23 20:00

Link to the spanish version:

Click here [4]