Single Ascending Dose Study of Lu AF76432 in Healthy Young Men

NCT03531229 | Completed Phase 1

• 1 other identifier: 17479A
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate safety, tolerability and pharmacokinetics of the drug Lu AF76432 given as single oral ascending doses to healthy young men

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of participants with Treatment-Emergent Adverse Events

  Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination)

  From dosing to 12 days

Secondary Outcomes (4)

• AUC0-t

  From dosing to 72 hours post dose

• Cmax

  From dosing to 72 hours post dose

• AUC0-inf

  From dosing to 72 hours post dose

• CL/F

  From dosing to 72 hours post dose

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo to Lu AF76432

Drug: Placebo

Lu AF76432

EXPERIMENTAL

Lu AF76432

Drug: Lu AF76432

Interventions

Placebo DRUG

Placebo to Lu AF76432 oral solution

Placebo

Lu AF76432 DRUG

Lu AF76432 oral solution 2.5 mg/ml. Starting dose will be 3,5 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s).

Lu AF76432

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy young non-smoking men ≥18 years of age and ≤45 years of age at the Screening Visit and a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit.

You may not qualify if:

• The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder or the subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason
• The subject has taken any investigational medicinal product \<3 months prior to the first dose of IMP

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

Parexel Early Phase Clinical Unit

Harrow, United Kingdom

Location

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 36 Subjects are planned for enrolment, with 6 subjects per cohort. The subjects will be randomized to Lu AF76432 or placebo in a 4:2 ratio per cohort. A maximum of 2 additional cohorts of young healthy men will be permitted thereby allowing investigation of a maximum of 48 subjects

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 21, 2018
• Study Start: April 17, 2018
• Primary Completion: February 22, 2019
• Study Completion: February 22, 2019
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

GB (1)