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A Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Cystinosis.

The objective of this pivotal study is to assess the long-term safety, tolerability, pharmacokinetics and pharmacodynamics of RP103 in pediatric and adult patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support…

Probiotic functionality of several probiotic supplements during gastro-intestinal transit in vivo in healthy human subjects

Primary objectiveTo measure the conversion rate of mono- and disaccharides into oligosaccharides and mannitol in the digestive tract by the action of food grade micro-organisms Secondary objectivesTo measure pH of gastric and duodenal fluids at…

Acute effects of capsaicin on energy expenditure, fat oxidation and satiety in negative energy balance

To investigate the acute effects of capsaicin on energy expenditure, substrate oxidation, appetite profile and ad libitum energy intake during negative energy balance.

Dietary protein requirements and caloric over-consumption on unbalanced diets

To determine ad libitum daily energy intake, energy balance and appetite profile in response to protein/carbohydrate and fat ratio over 12 consecutive days, and in relation to age, gender, BMI and FTO polymorphisms.

Effects of beef protein consumption on energy intake - The protein leverage hypothesis

To determine ad libitum daily energy intake in response to protein/carbohydrate and fat ratio over 12 consecutive days, and in relation to age, gender, BMI and FTO gene alleles.

A Global, Phase 1/2, Open-Label, Dose Optimization Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of mRNA-3705 in Participants with Isolated Methylmalonic Acidemia Due to Methylmalonyl-CoA Mutase Deficiency

This study has been transitioned to CTIS with ID 2022-502492-32-00 check the CTIS register for the current data. PrimaryPart I: Evaluate the safety and tolerability of mRNA-3705 administered via IV infusion to participants with isolated MMA due to…

An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome

Primary Objectives: Safety Assessments: Effect of Administration of Relacorilant on: • Incidence of TEAEs (assessed monthly): TEAEs, SAEs, treatment-related TEAEs, TEAEs leading to early discontinuation of study treatment• Clinical laboratory tests…