Condition category
Urological and Genital Diseases
Date applied
17/11/2020
Date assigned
25/11/2020
Last edited
25/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
A new oral film containing sildenafil citrate, the active ingredient in Viagra, which is used to treat erectile dysfunction (ED), has been recently developed. It dissolves very rapidly in the oral mouth, with no need for drinking or chewing, thus providing an alternative to the marketed solid oral forms (tablets) in the treatment of ED. This study aims to investigate whether the oral film is absorbed in the same way following two different administration methods: the approved supralingual (dissolved above the tongue) administration and the alternative sublingual (dissolved underneath the tongue) administration.

Who can participate?
Healthy men aged 18-45 years

What does the study involve?
The study has two periods, and participants will be randomly allocated into one section and then will rotate through each period such that every participant completes all periods of the trial but the order will vary depending on the period they are initially allocated to:
Period A: Single dose of the study drug dissolved under the tongue, under fasting
conditions
Period B: Single dose of the study drug dissolved above the tongue, under fasting conditions

There will be a break of at least 5 days between the periods.

The blood level of sildenafil is measured before taking the study drug and again after 6, 15, 30, 45 min and 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12 h.

What are the possible benefits and risks of participating?
There are no known benefits or risks to participants taking part in this study.

Where is the study run from?
CROSS Research S.A., Phase I Unit (Switzerland)

When is the study starting and how long is it expected to run for?
From November 2017 to December 2017

Who is funding the study?
IBSA Institut Biochimique SA (Switzerland)

Who is the main contact?
Milko Radicioni, MD
clinic@croalliance.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Milko Radicioni

ORCID ID

http://orcid.org/0000-0002-3940-8375

Contact details

CROSS Research S.A
Phase I Unit
Via F.A. Giorgioli 14
Arzo
6864
Switzerland
+41.91.64.04.450
clinic@croalliance.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Study CRO-PK-17-325, Sponsor code 17CH-SDF06

Study information

Scientific title

Pilot bioavailability study of sildenafil 50 mg orodispersible film administered by the supralingual and the sublingual route to healthy men

Acronym

Study hypothesis

To compare the bioavailability of sildenafil and its metabolite N-desmethyl-sildenafil after single dose of sildenafil IBSA 50 mg orodispersible film (ODF), administered by the supralingual and the sublingual route.

Ethics approval

Approved 25/09/2017, Cantonal Ethics Committee of the Canton of Ticino (Cantonal Ethics Committee, c/o Health Office, Via Orico 5, 6501 Bellinzona, Switzerland; +41 91 814 30 57; dss-ce@ti.ch), ref: CE3268, BASEC ref: 2017-01622

Study design

Single dose, open, randomised, 2-way cross-over pilot bioavailability study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet

Condition

Erectile Dysfunction

Intervention

The study has two periods, and participants will be randomly allocated into one section and then will rotate through each period such that every participant completes all periods of the trial but the order will vary depending on the period they are initially allocated to:
Period A: Single dose of 50 mg sildenafil orodispersible film (ODF) (IBSA Institut Biochimique S.A., Switzerland) by the sublingual administration routes, under fasting conditions
Period B: Single dose of 50 mg sildenafil orodispersible film (ODF) (IBSA Institut Biochimique S.A., Switzerland) by the supralingual administration routes, under fasting conditions

There will be a break of at least 5 days between the periods.

The plasma level of sildenafil is measured before taking the study drug (baseline/0 min) and again after 6, 15, 30, 45 min and 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12 h.

Intervention type

Drug

Phase

Phase I

Drug names

sildenafil

Primary outcome measure

1. Plasma sildenafil maximum serum concentration (Cmax) and area under the plasma drug concentration-time curve (AUC0-t) are measured from plasma samples taken at baseline, and 6, 15, 30, and 45 min, and 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 h

Secondary outcome measures

1. Plasma sildenafil time take to reach Cmax (tmax), relative bioavailability (Frel), and, if feasible, area under the plasma concentration-time curve from time zero to infinity (AUC0-∞), elimination half-life (t1/2), and terminal disposition rate constant/terminal rate constant (λz) are measured from plasma samples taken at baseline, and 6, 15, 30, and 45 min, and 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 h
2. Plasma N-desmethyl-sildenafil time take to reach Cmax (tmax), area under the plasma drug concentration-time curve (AUC0-t), relative bioavailability (Frel), and, if feasible, area under the plasma concentration-time curve from time zero to infinity (AUC0-∞), elimination half-life (t1/2), and terminal disposition rate constant/terminal rate constant (λz) are measured from plasma samples taken at baseline, and 6, 15, 30, and 45 min, and 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 h

Overall trial start date

06/09/2017

Overall trial end date

13/12/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Signed written informed consent before inclusion in the study
2. Male participants aged between 18-45 years inclusive
3. Body Mass Index (BMI) between 18.5-30 kg/m² inclusive
4. Systolic blood pressure between 100-139 mmHg, diastolic blood pressure between 50-89 mmHg, heart rate between 50-90 bpm (all measured after 5 min at rest in the sitting position)
5. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects, to co-operate with the investigator, and to comply with the requirements of the entire study

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

12

Total final enrolment

12

Participant exclusion criteria

1. Clinically significant abnormalities on electrocardiogram (12-lead ECG in supine position)
2. Clinically significant abnormal physical findings which could interfere with the objectives of the study
3. Clinically significant abnormal laboratory values indicative of physical illness
4. Ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients, or history of anaphylaxis to drugs or allergic reactions in general, which the investigator considered could affect the outcome of the study
5. Significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that could interfere with the aim of the study; history of vision or hearing problems related to drugs of the PDE5 inhibitor pharmacological class; history of priapism; anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease); or history of ophthalmologic diseases like non-arteritic anterior ischemic optic neuropathy or retinitis pigmentosa

Recruitment start date

27/11/2017

Recruitment end date

13/12/2017

Locations

Countries of recruitment

Switzerland

Trial participating centre

CROSS Research S.A., Phase I Unit
Via F.A. Giorgioli 14
Arzo
6864
Switzerland

Sponsor information

Organisation

IBSA Institut Biochimique (Switzerland)

Sponsor details

via del Piano
Pambio-Noranco
6915
Switzerland
+41.58.360.10.00
sd@ibsa.ch

Sponsor type

Industry

Website

http://ibsa-international.com/

Funders

Funder type

Industry

Funder name

IBSA Institut Biochimique S.A.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results published in 2018.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

01/08/2018

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2018 results in https://dx.doi.org/10.1007%2Fs40261-018-0665-x

Publication citations

Additional files

Editorial Notes

25/11/2020: Trial’s existence confirmed by the Cantonal Ethics Committee of the Canton of Ticino.