First-in-human Study to Assess the Safety and Pharmacokinetics of LML134 in Healthy Volunteers

NCT ID: NCT02334449

Last Updated: 2016-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-02-29

Brief Summary

Phase I study to assess the safety, tolerability and pharmacokinetics of ascending single and multiple doses of the investigational medicinal product in healthy volunteers

Conditions

Healthy Volunteers

Keywords

healthy volunteers

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Single dose study part

there will be 8 cohorts of healthy volunteers dosed with single doses of LML134 (8 planned dose levels) or with placebo and 2 potential additional cohorts (also dosed with single dose of LML134 or placebo)

Group Type: EXPERIMENTAL

LML134

Intervention Type: DRUG

LML134 will be administered first as single doses and then as multiple doses

Placebo

Intervention Type: DRUG

All study cohorts (except food effect cohort) are placebo controlled

Multiple dose study part

there will be 3 cohorts of healthy volunteers dosed with multiple doses of LML134 (3 planned dose levels) or placebo and one potential additional cohort (also dosed with multiple doses of LML134 or placebo)

Group Type: EXPERIMENTAL

LML134

Intervention Type: DRUG

LML134 will be administered first as single doses and then as multiple doses

Placebo

Intervention Type: DRUG

All study cohorts (except food effect cohort) are placebo controlled

Interventions

LML134

LML134 will be administered first as single doses and then as multiple doses

Intervention Type: DRUG

Placebo

All study cohorts (except food effect cohort) are placebo controlled

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male and female subjects age 18 to 55 years of age included, and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.
• Written informed consent must be obtained before any assessment is performed.
• Able to communicate well with the Investigator, to understand and comply with the requirements of the study.

Exclusion Criteria

• History or presence of epilepsy or of seizures or convulsions of any kind.
• Any clinically relevant abnormalities identified in the resting EEG during screening, or pre-ictal signs or other clinically relevant abnormalities in the hyperventilation or intermittent photic stimulation EEG during screening.
• History of head trauma leading to clinically significant symptoms in the past two years.
• Applies only to subjects enrolled in Part 2 MAD. Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years.
• Significant illness including any clinically significant infectious disease which has not resolved within two (2) weeks prior to initial dosing.
• History or presence of significant hematological abnormalities or immunodeficiency or any condition that might compromise the immune system (infection, vaccination), of any etiology as indicated by clinically significantly abnormal values of any of the following hematologic parameters: thrombocyte, RBC count, total WBC count and differentials presented as % of total white blood cell count and as absolute concentrations.
• History or presence of any thyroid disease as indicated by any clinically relevant abnormality on thyroid stimulating hormone test (TSH).
• History or presence of any chronic eye disease other than refractive error, strabismic amblyopia, or anisometropic amblyopia.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Novartis Pharmceuticals

Locations

Novartis Investigative Site

Berlin, , Germany

Countries

United Kingdom; Germany

Other Identifiers

2014-000937-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLML134X2101

Identifier Type: -

Identifier Source: org_study_id