Avulsed nerve roots of the brachial plexus Nervous System Diseases Spinal cord injury
Conditions
Interventions
The study comprises 2 parts: Part A employs a single ascending dose (SAD) design with a separate food interaction (FI) arm for one cohort, and Part B employs a multiple ascending dose (MAD) design.
P
this will include sentinel dosing of the first 2 participants (1 active, 1 placebo) in each cohort with the remainder of the cohort (n=6
5 active and 1 placebo) being dosed at least 24 hours later.
Part A FI will include 8 participants (all on active treatment – no sentinel participants) who will be randomised in a two-way crossover s
Sponsors
King's College London
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy males 2. Aged 19 to 45 years at screening 3. Able to understand and willing to follow the requirements for the study and provide written informed consent 4. Willing to avoid direct sunlight, use sun cream and cover arms and legs and to wear sunglasses and sunhat when outside during treatment and until final visit 5. Non-smokers from at least 3 months before receiving the first dose of study drug and for the duration of the study 6. Participants who are sexually active must agree to use barrier contraception with a spermicide from the time of the first dose until 3 months after the last dose (participants whose female partners are trying to become pregnant will be excluded) 7. Body mass index (BMI) =18 and =30 kg/m2 8. Body weight =55 kg at screening
Exclusion criteria
Exclusion criteria: 1. Current or recent (within 3 months of screening) use of sunbeds 2. Current or recent (less than 5 years) history of drug or alcohol abuse or a positive drugs of abuse test 3. Current or past history of psychiatric conditions or suicidal ideation 4. History or presence of any clinically relevant allergy 5. Consumption of prescription or over-the-counter medications (including vitamins, herbal and mineral supplements) within 14 days prior to study drug administration until (with the exception of occasional paracetamol) the end of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence and severity of adverse events up to 48 hours after the last dose 2. Incidence of serious adverse events up to 48 hours after the last dose 3. Change from baseline in vital signs (Heart rate, blood pressure, oral temperature and respiratory rate) measured pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 36 and 48 h after the dose 4. Depression assessed using PHQ-9 questionnaire at 48 h post-dose 5. Anxiety assessed using GAD-7 questionnaire at 48 h post-dose 5. Change from baseline in laboratory data, including haematology tests (haemoglobin, hematocrit, white blood cells and platelets) and blood chemistry (alanine aminotransferase [ALT], albumin, alkaline phosphatase, aspartase aminotransferase, blood urea nitrogen [BUN], calcium, chloride, creatinine, glucose, glycosylated haemoglobin [Hb1Ac], potassium, sodium, thyroid stimulating hormone [TSD], thyroxine, total bilirubin, lipids, urea and electrolytes, creatinine and liver function tests [LFTs]) 1 day pre-dose and 24 h post-dose 6. Change from baseline in 12-lead ECGs performed after resting for approximately 10 minutes in the semi-recumbent position pre-dose and at 0.5, 1, 2, 4, 8, 12, 24 and 48 h post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma and urine concentration-time profiles assessed using blood samples taken pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 36 and 48 h after the dose and urine collected pre-dose and throughout the study up to 48 h post-dose 2. Plasma and urine pharmacokinetic parameters, including but not limited to Cmax, Tmax, AUC, half-life, fraction eliminated unchanged in urine and renal clearance, as data permit, using blood samples taken pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 36 and 48 h after the dose and urine collected pre-dose and throughout the study up to 48 h post-dose | — |
Countries
England, United Kingdom
Contacts
Public ContactJonathan Corcoran
Outcome results
None listed