A Phase I, prospective, double-blind, randomised, placebo-controlled, dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KCL-286 and the effects of food in healthy male participants
Damage to nerves in the arm, for example from the trauma possibly caused in a road traffic accident, can result in the nerve roots being torn from the spinal cord, known as a brachial plexus injury. In these situations the main effects often seen are problems with movement (motor control), loss of sensations (sensory control) and pain. Once the nerves have been torn from the spinal cord a scar is formed at the site of the injury and this becomes a barrier to recovery as it prevents the nerves growing back in the spinal cord. Current treatments in place for brachial plexus injuries often do not result in full return of functions or sufficient pain relief. Some treatments used involve surgery to implant nerves; this technique has been shown to result in some return of motor function and easing of pain but not return of sensations and it is thought that this may in part be due to the formation of the scar.
This is the first study to give KCL-286 to humans. It will be given to healthy males (who do not have brachial plexus injuries) to investigate whether it has any side effects in humans and also to determine appropriate doses to investigate in patients with brachial plexus injuries.
In this part of the study (Part A2 impact of food), you will be placed into one cohort (group) which will involve 8 participants. All of the participants in the group will receive the study medication on two separate occasions as this part is a cross-over trial. In a ‘cross-over trial’ the participants each have the different treatments in turn. There will be a break between treatments (wash-out period) so that the first treatment is cleared from your body before you start the new treatment. For this study you will receive the study medication either while you are fasted or after you have had a high fat standard breakfast. The order which you receive the study medication (fasted or fed) will be decided by chance (randomly).
To date there have been no related safety concerns from the participants who have received a dose of study drug.
- You must be aged between 19 and 45
- You must not have participated in another clinical trial within 3 months of the first treatment period.
- You must have an appropriate work permit (if you are not from the EU)
- You must have a Body Mass Index of ≥ 18 kg/m2 to ≤ 30 kg/m2
- Be a non-nicotine user (not smoked or used other nicotine products within 3 months before the screening visit)
- Have no clinically relevant medical conditions or allergies
- Not taking any medications, herbal supplements, vitamins or minerals, except a maximum of 2g of paracetamol per 24 hours
- Be willing to avoid direct sunlight, use sun cream, cover your arms and legs and wear a sunhat and sunglasses when outside for the duration of the study
- Not have used a sunbed for 3 months before screening and for the duration of the study and one month after
- Be willing to not consume alcohol, caffeine, xanthine and poppy seed containing food/drinks within 48 hours of each visit. At all other times, be willing to limit caffeine to 500mg per day and alcohol to 21 units per week.
- Be willing to not consume grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade or other products containing grapefruit or Seville oranges for the duration of the study
- Be willing to use condoms with spermicide for the duration of the study and for 3 months after the last visit and any female partners should be on an effective form of contraception during this period
- You are willing to take the study medication which contains gelatine
- Be available for every required date for the duration of the study
- Be willing to consume a high fat breakfast
|Visit 1 - Screening||Surrey CRC||Approximately 5 hours|
|Visit 2 - Residential Stay||Surrey CRC||3 Nights|
|Visit 2A - Outpatient||Surrey CRC||Approximately 30 minutes if applicable|
|Visit 3 - Residential Stay||Surrey CRC||3 Nights|
|Visit 3A - Outpatient||Surrey CRC||Approximately 30 minutes if applicable|
|Visit 4 Follow Up||Surrey CRC||2 -3 hours|
You will receive an inconvenience allowance of £1,350 for participating in this study:-
Screening Visit - £50
Up to the end of Visit 2 (from screening to end Visit 2) - £400
Up to follow-up visit (from end Visit 2 to end Visit 4) - £900
You will also be reimbursed for reasonable travelling expenses incurred to and from the Surrey CRC for this study of up to £40 per visit depending on where you live. The payments, depending on your circumstances, may be liable to income tax and may affect any Government benefits you receive.
The need for the visit after visits 2 and 3 (72 hours after receiving the study medication each time, (which will be the day following your discharge from the residential stay) will be determined based on results from participants in the earlier cohorts. If it is decided to go ahead with these extra visits you will be reimbursed £25 for each visit for time and inconvenience plus travel.
If you need to attend for any additional visits (for example if your screening procedures need to be split on more than one day) you will be reimbursed for your travel for this extra visit.
If you would like more information under no obligation, or are interested in taking part and wish to complete a telephone health screen, please contact the Clinical Research Recruitment team on: Freephone 0800 269 847, by email firstname.lastname@example.org and if you have not done so already, please register with us on here