Condition category
Not Applicable
Date applied
23/01/2015
Date assigned
30/01/2015
Last edited
15/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Levothyroxine is a synthetic thyroid hormone that is normally used to substitute the natural hormone when the thyroid, for several reasons, does not produce this hormone at all or does not produce it in sufficient amounts. The absorption of levothyroxine is affected by the intake of food and the recommendation is to take it in the fasting state and wait between 30 min and 1 hour before having breakfast. Exactly how long one should wait before the meal and whether different formulations require different fasting times have not been investigated. The aim in this study is to compare the absorption profile of oral levothyroxine administered at a single dose in healthy volunteers at different times before breakfast.

Who can participate?
Women, aged 18–50 years old, who are generally healthy

What does the study involve?
Healthy volunteers will be randomly allocated to oral levothyroxine as a single dose (600 µg) at different times: they will take two or three single doses of levothyroxine in the fasting state or 15 minutes and/or 30 minutes before a light breakfast.

What are the possible benefits and risks of participating?
Levothyroxine is usually well tolerated, although, in the event of hyperdosing, symptoms may occur such as palpitations, alterations of the cardiac rhythm, increased heart rate frequency, muscular cramps, insomnia, diarrhoea, vomiting, nervousness, headache, sweating, weight decrease, tremors, alterations of the menstrual cycle or loss of hair. There are no direct benefits from the participation.

Where is the study run from?
Cross Research SA (Switzerland)

When is the study starting and how long is it expected to run for?
From January 2015 to September 2015

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

Who is the main contact?
Mrs Claudia Scarsi

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Claudia Scarsi

ORCID ID

Contact details

Via del Piano
Pambio-Noranco
6915
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14CH/T412

Study information

Scientific title

Effect of food on levothyroxine absorption following a single oral dose of 600 µg in healthy women: an randomised open-label pilot study

Acronym

Study hypothesis

To verifiy the absorption of levothyroxine after meals.

On 30/06/2015 the following changes were made to the trial record:
1. The overall trial end date was changed from 30/05/2015 to 30/09/2015.
2. The target number of participants was changed from 30 to 40.

Ethics approval

Comitato Etico Cantonale (Switzerland), 20/01/2015 (amendment n. 2 21/04/2015), reference number: 2871

Study design

Randomised open-label three-way bioavailability pilot study in two parts

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Oral levothyroxine

Intervention

Healthy volunteers were administered oral levothyroxine as a single dose (600 mcg):
1. In the fasting state
2. 15 minutes before a light breakfast
3. 30 minutes before a light breakfast

Intervention type

Drug

Phase

Not Applicable

Drug names

Levothyroxine

Primary outcome measures

Effect of food on levothyroxine sodium bioavailability by comparison of the rate (Cmax) and extent (AUC0-t) of absorption of serum levothyroxine after a single dose of 600 µg: measured over 24 hours after each single dose, by repeated blood sampling and analytical quantitation of the serum concentration of levothyroxine

Secondary outcome measures

Effect of food on the secondary levothyroxine pharmacokinetic parameters after a single dose of 600 µg: measured over 24 hours after each single dose, by repeated blood sampling and analytical quantitation of the serum concentration of levothyroxine

Overall trial start date

21/01/2015

Overall trial end date

30/09/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Signed written informed consent before inclusion in the study
2. Age 18–50 years old
3. Body-mass index: 18.5–27 kg/m2
4. Vital signs: systolic blood pressure 100–139 mmHg, diastolic blood pressure 50–89 mmHg, heart rate 50–90 beats per minute, measured after 5 minutes at rest in the sitting position
5. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and comply with the requirements of the entire study
6. Women of child-bearing potential must be using at least one of the following reliable methods of contraception and must continue up to 30 days after the last investigational medicinal product administration: 6.1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit
6.2. Non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit
6.3. Male sexual partner who agrees to use a male condom with spermicide
6.4. Sterile sexual partner
6.5. Non-child-bearing potential or in post-menopausal status for at least 1 year
7. All thyroid function tests within normal limits

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

40

Participant exclusion criteria

1. Electrocardiogram 12-leads (supine position): clinically significant abnormalities
2. Physical findings: clinically significant abnormal physical findings that could interfere with the objectives of the study
3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
4. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
5. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular (including active arrhythmia or history of arrhythmia, particularly atrial fibrillation), respiratory, skin, haematological, genitourinary or neurological diseases that may interfere with the aim of the study; history of endocrine abnormalities, particularly thyroid, hypophysis and hypothalamus dysfunction; autoimmune diseases such as Basedow-Graves and Hashimoto morbi; neoplasia
6. Medications, including over the counter drugs and herbal remedies for 2 weeks before the start of the study
7. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study; the 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
8. Blood donations for 3 months before this study
9. Drug, alcohol, caffeine, tobacco: history of drug, alcohol (more than one drink per day defined according to the USDA Dietary Guidelines 2010), caffeine (more than five cups of coffee or tea per day) or tobacco abuse (at least 10 cigarettes per day)
10. Positive drug test results at screening or day–1
11. Positive alcohol breath test at day –1
12. Abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study
13. Vegetarians
14. Positive or missing pregnancy test at screening or day–1
15. Pregnant or lactating women

Recruitment start date

01/02/2015

Recruitment end date

15/06/2015

Locations

Countries of recruitment

Switzerland

Trial participating centre

Cross Research SA
6894
Switzerland

Sponsor information

Organisation

IBSA Institut Biochimique SA

Sponsor details

Via del Piano
Pambio-Noranco
6915
Switzerland

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

IBSA Institut Biochimique SA (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

No publication/dissemination plan has been made so far.

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes