HelminthiasisPhase 1NCT03173742
Bioavailability and Safety of Two Oral Fixed Dose Preparations Containing 18 mg Ivermectin (IVM 18 MG TABLETS, LICONSA S.A., Spain) Versus Reference Dosing (Weight Based) Containing 6 mg Ivermectin (REVECTINA®, Abbott Laboratórios do Brasil Ltda, Brazil)
A Phase 1 study testing T1, T2, T3, T1,T3,T2 and T2,T1,T3 in people with Helminthiasis, run by Insud Pharma.
Trial summary
Evaluation of the bioavailability and safety of one oral preparation containing fixed dose 18 mg ivermectin (IVM 18 MG TABLETS, LICONSA S.A., Spain) or two oral preparations containing fixed dose 18 mg ivermectin (IVM 36 MG TABLETS, LICONSA S.A., Spain) vs. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Helminthiasis
- What is being tested?
- T1, T2, T3, T1,T3,T2 and T2,T1,T3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Jan 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian subjects of either gender (male or female) with an age between 18 and 45 years (both inclusive).
- Medical history and physical examination with no relevant abnormal findings.
- No evidence of significant disease (organic or psychiatric) based on medical history, physical examination and complementary tests.
- Laboratory tests (complete hematology, clinical chemistry and urinalysis).
- Vital signs (systolic and diastolic blood pressure, heart rate and temperature) and electrocardiogram (ECG) record within normal range at screening.
- Participating female volunteers must use a reliable contraception method not containing hormones. List of accepted contraception method includes barrier methods (i.e. female/male condoms, diaphragms, spermicides), voluntary sterilization (female tubal occlusion) or non-medicated intrauterine devices (IUD) (i.e. inert or copper-releasing). Abstention is not considered a reliable contraception method.
Show all 10Show fewer
- For female volunteers only: they must declare that they did not intend to become pregnant in the last month prior to screening and they do not intend to become pregnant during one month following the last study drug administration.
- Voluntary participation in the study, with written informed consent from the volunteer.
- The subject agrees to abstain from beverages or food containing methylxanthines (coffee, tea, cola, energy drinks, chocolate etc.), St John's Wort, vitamins, herbal remedies and chewing-gum for 48 hours prior to study drug administration and during each study period.
- The subject agrees to abstain from beverages or food containing grapefruit for 14 days prior to the first study drug administration and during the study (until last sample from the last period).
Who cannot join
- Background of allergy, idiosyncrasy or hypersensitivity to the study drugs or its excipients.
- Heavy consumer of stimulating drinks (>5 cups of coffee, tea, chocolate or cola drinks per day).
- Background of alcoholism or drug dependence in the last one year or daily consumption of alcohol > 40 gr/day for men or > 24 gr/day for women.
- Use of any medication within 15 days prior to taking the study treatment, including over-the-counter medications and medicinal plants (except for the use of paracetamol in short-term symptomatic treatments).
- Positive serology for hepatitis B, C or HIV.
- Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological or neurological disease or other chronic diseases.
Show all 16Show fewer
- Smokers or ex-smokers that gave up smoking less than 1 year prior to the study (day 1 of period I)
- Pregnancy or lactation status for female subjects.
- Participation in another clinical trial during the 3 months before starting the current trial.
- Donate blood in the 8 weeks prior to starting the study.
- Undergone major surgery during the previous 6 months.
- Clinically significant abnormal ECG with clinical significance in accordance with the CIM's clinical criterion
- Restrictive vegetarian diet
- Positive results to the breath alcohol test at screening or at Day -1
- Positive results to the drug abuse checks (urine test for: amphetamines, cannabinoids, opiates, benzodiazepines and cocaine) at screening or at admission on Day -1
- Epidemiological risk of being infected by Loa loa or other filariases, defined as those who have lived or have travelled to any of the following countries: Angola, Cameroon, Central Africa Republic, Chad, Congo, Democratic Republic of the Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan.
About this study
Official title: Bioavailability and Safety of Two Oral Fixed Dose Preparations Containing 18 mg Ivermectin (IVM 18 MG TABLETS, LICONSA S.A., Spain) Versus Reference Dosing (Weight Based) Containing 6 mg Ivermectin (REVECTINA, Abbott Laboratórios do Brasil Ltda, Brazil)
Evaluation of the bioavailability and safety of one oral preparation containing fixed dose 18 mg ivermectin (IVM 18 MG TABLETS, LICONSA S.A., Spain) or two oral preparations containing fixed dose 18 mg ivermectin (IVM 36 MG TABLETS, LICONSA S.A., Spain) vs. reference dosing (weight based) of reference drug containing 6 mg ivermectin (REVECTINA®, Abbott Laboratórios do Brasil Ltda, Brazil) in fasting conditions. A monocentric, open, randomized, single dose, three-period crossover trial in healthy volunteers.
- Conditions
- Helminthiasis
- Being tested
- T1, T2, T3, T1,T3,T2, T2,T1,T3, T2,T3,T1, T3,T1,T2
- Medical subject headings
- Helminthiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T1, T2, T3Drug
Also called Treatment 1-2-3
T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)
T1,T3,T2Drug
Also called Treatment 1-3-2
T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)
T2,T1,T3Drug
Also called Treatment 2-1-3
T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)
T2,T3,T1Drug
Also called Treatment 2-3-1
T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)
T3,T1,T2Drug
Also called Treatment 3-1-2
T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)
T3,T2,T1Drug
Also called Treatment 3-2-1
T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)
| Study group | Role | What they receive |
|---|---|---|
| T1, T2, T3 | Experimental | T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets) Receives: Drug: T1, T2, T3 |
| T1, T3, T2 | Experimental | T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets) Receives: Drug: T1,T3,T2 |
| T2,T1,T3 | Experimental | T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets) Receives: Drug: T2,T1,T3 |
| T2,T3,T1 | Experimental | T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets) Receives: Drug: T2,T3,T1 |
| T3,T1,T2 | Experimental | T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets) Receives: Drug: T3,T1,T2 |
| T3,T2,T1 | Experimental | T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets) Receives: Drug: T3,T2,T1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint evaluated will be the PK parameters that define bioavailability in extent Ln [AUC0t]
For group 3
Measured: up to day 7
Primary endpoint evaluated will be the PK parameters that define bioavailability in extent in rate: Ln [Cmax] for each treatment in healthy volunteers with high weight (Group 3), calculated by means of a non-compartmental analysis.
For group 3
Measured: up to day 7
Secondary outcomes (21)
Relative bioavailability for each treatment and for groups 1 and 2 will be evaluated with the PK parameters that define bioavailability in extent Ln [AUC0t]
for group 1 and 2
Measured: up to day 7
Relative bioavailability for each treatment and for groups 1 and 2 will be evaluated with the PK parameters that define bioavailability in extent in rate: Ln [Cmax]
for group 1 and 2
Measured: up to day 7
AUC0t (for non-compartmental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Measured: up to day 7
AUC0∞ (for non-compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Measured: up to day 7
%AUC extra (residual area) (for non-compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Measured: up to day 7
tmax (for non-compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Measured: up to day 7
tlag (for non-compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Measured: up to day 7
Cl/F (for non-compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Measured: up to day 7
V/F (for non-compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Measured: up to day 7
t1/2 (for non-compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Measured: up to day 7
Ke (for non-compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Measured: up to day 7
MRT (for non-compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Measured: up to day 7
Cmax (for non-compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Measured: up to day 7
tlag (for compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Measured: up to day 7
ka (for compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Measured: D7
Cl/F(for compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Measured: up to day 7
V/F (for compartimental analysis)
PK profile for each treatment and each study group will be evaluated by means of a compartmental and non-compartmental analysis
Measured: up to day 7
vital signs
To asses safety and tolerability of the treatments
Measured: up to week 6
laboratory analysis
To asses safety and tolerability of the treatments
Measured: up to week 6
Incidence of adverse events.
To asses safety and tolerability of the treatments
Measured: up to week 6
ECG
To asses safety and tolerability of the treatments
Measured: up to week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study startMar 2016
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HelminthiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insud Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173742
- Sponsor's protocol ID
- MS842-101
- Other IDs
- 2015-005690-20, 2015
- Status last verified
- May 2017
- First submitted
- 17 May 2017
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Munoz J, Ballester MR, Antonijoan RM, Gich I, Rodriguez M, Colli E, Gold S, Krolewiecki AJ. Safety and pharmacokinetic profile of fixed-dose ivermectin with an innovative 18mg tablet in healthy adult volunteers. PLoS Negl Trop Dis. 2018 Jan 18;12(1):e0006020. doi: 10.1371/journal.pntd.0006020. eCollection 2018 Jan.
PubMed 29346388
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability and Safety of Two Oral Fixed Dose Preparations Containing 18 mg Ivermectin (IVM 18 MG TABLETS, LICONSA S.A., Spain) Versus Reference Dosing (Weight Based) Containing 6 mg Ivermectin (REVECTINA, Abbott Laboratórios do Brasil Ltda, Brazil)
- ClinicalTrials.gov ID
- NCT03173742
- Acronym / sponsor ID
- MS842-101
- Conditions
- Helminthiasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Insud PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 2 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the bioavailability and safety of one oral preparation containing fixed dose 18 mg ivermectin (IVM 18 MG TABLETS, LICONSA S.A., Spain) or two oral preparations containing fixed dose 18 mg ivermectin (IVM 36 MG TABLETS, LICONSA S.A., Spain) vs. reference dosing (weight based) of reference drug containing 6 mg ivermectin (REVECTINA®, Abbott Laboratórios do Brasil Ltda, Brazil) in fasting conditions. A monocentric, open, randomized, single dose, three-period crossover trial in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| T1, T2, T3 | Experimental | Drug: T1, T2, T3T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets) |
| T1, T3, T2 | Experimental | Drug: T1,T3,T2T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets) |
| T2,T1,T3 | Experimental | Drug: T2,T1,T3T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets) |
| T2,T3,T1 | Experimental | Drug: T2,T3,T1T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets) |
| T3,T1,T2 | Experimental | Drug: T3,T1,T2T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets) |
| T3,T2,T1 | Experimental | Drug: T3,T2,T1T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Caucasian subjects of either gender (male or female) with an age between 18 and 45 years (both inclusive).
- Medical history and physical examination with no relevant abnormal findings.
- No evidence of significant disease (organic or psychiatric) based on medical history, physical examination and complementary tests.
- Laboratory tests (complete hematology, clinical chemistry and urinalysis).
- Vital signs (systolic and diastolic blood pressure, heart rate and temperature) and electrocardiogram (ECG) record within normal range at screening.
Key exclusion criteria (16 listed)
- Background of allergy, idiosyncrasy or hypersensitivity to the study drugs or its excipients.
- Heavy consumer of stimulating drinks (>5 cups of coffee, tea, chocolate or cola drinks per day).
- Background of alcoholism or drug dependence in the last one year or daily consumption of alcohol > 40 gr/day for men or > 24 gr/day for women.
- Use of any medication within 15 days prior to taking the study treatment, including over-the-counter medications and medicinal plants (except for the use of paracetamol in short-term symptomatic treatments).
- Positive serology for hepatitis B, C or HIV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T1, T2, T3Also: Treatment 1-2-3T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets) | Drug | T1, T2, T3 |
| T1,T3,T2Also: Treatment 1-3-2T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets) | Drug | T1, T3, T2 |
| T2,T1,T3Also: Treatment 2-1-3T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets) | Drug | T2,T1,T3 |
| T2,T3,T1Also: Treatment 2-3-1T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets) | Drug | T2,T3,T1 |
| T3,T1,T2Also: Treatment 3-1-2T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets) | Drug | T3,T1,T2 |
| T3,T2,T1Also: Treatment 3-2-1T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight. T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets) | Drug | T3,T2,T1 |
Primary outcome
Primary endpoint evaluated will be the PK parameters that define bioavailability in extent Ln [AUC0t]
Time frame: up to day 7
For group 3
Primary endpoint evaluated will be the PK parameters that define bioavailability in extent in rate: Ln [Cmax] for each treatment in healthy volunteers with high weight (Group 3), calculated by means of a non-compartmental analysis.
Time frame: up to day 7
For group 3
21 secondary outcomes
Relative bioavailability for each treatment and for groups 1 and 2 will be evaluated with the PK parameters that define bioavailability in extent Ln [AUC0t]
Time frame: up to day 7
Relative bioavailability for each treatment and for groups 1 and 2 will be evaluated with the PK parameters that define bioavailability in extent in rate: Ln [Cmax]
Time frame: up to day 7
AUC0t (for non-compartmental analysis)
Time frame: up to day 7
AUC0∞ (for non-compartimental analysis)
Time frame: up to day 7
%AUC extra (residual area) (for non-compartimental analysis)
Time frame: up to day 7
tmax (for non-compartimental analysis)
Time frame: up to day 7
tlag (for non-compartimental analysis)
Time frame: up to day 7
Cl/F (for non-compartimental analysis)
Time frame: up to day 7
V/F (for non-compartimental analysis)
Time frame: up to day 7
t1/2 (for non-compartimental analysis)
Time frame: up to day 7
Ke (for non-compartimental analysis)
Time frame: up to day 7
MRT (for non-compartimental analysis)
Time frame: up to day 7
Cmax (for non-compartimental analysis)
Time frame: up to day 7
tlag (for compartimental analysis)
Time frame: up to day 7
ka (for compartimental analysis)
Time frame: D7
Cl/F(for compartimental analysis)
Time frame: up to day 7
V/F (for compartimental analysis)
Time frame: up to day 7
vital signs
Time frame: up to week 6
laboratory analysis
Time frame: up to week 6
Incidence of adverse events.
Time frame: up to week 6
ECG
Time frame: up to week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Derived from this study: PubMed 29346388Munoz J, Ballester MR, Antonijoan RM, Gich I, Rodriguez M, Colli E, Gold S, Krolewiecki AJ. Safety and pharmacokinetic profile of fixed-dose ivermectin with an innovative 18mg tablet in healthy adult volunteers. PLoS Negl Trop Dis. 2018 Jan 18;12(1):e0006020. doi: 10.1371/journal.pntd.0006020. eCollection 2018 Jan.
- Individual participant dataSharing planned: Undecided
Related trials for Helminthiasis
RecruitingObservational study
Evaluation, Treatment and Monitoring of Patients With a Known or Suspected Parasitic Infection
Malaria, Intestinal Worms
Active, not recruitingObservational study
Host Response to Infection and Treatment in Filarial Diseases
Filariasis, Helminthiasis
RecruitingObservational study
Natural History of Treated Neurocysticercosis and Long-Term Outcomes
Cysticercosis, Neurocysticercosis
Not yet recruitingPhase 3
Follow-up Assessment of Change in Soil-transmitted Helminths Infection Intensity in Uganda
Ascariasis
RecruitingPhase 3
Better Options for Lymphatic Filariasis Treatment
Lymphatic Filariasis, Scabies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing T1, T2, T3, T1,T3,T2 and T2,T1,T3 in people with Helminthiasis, run by Insud Pharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint evaluated will be the PK parameters that define bioavailability in extent Ln [AUC0t] (time frame: up to day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03173742, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.